Registration Dossier

Administrative data

Description of key information

Acute Oral Toxicity (weight of evidence): LD50 > 5000 mg/kg bw, 2018

1. Acute Oral (Read-Across: undec-10-enal): LD50 > 5000 mg/kg bw, eq. or similar to OECD TG 401, 1971

2. Acute Oral (Read-Across: undec-9-enal): LD50 > 5000 mg/kg bw, eq. or similar to OECD TG 401, 1977

 

Acute Dermal Toxicity (weight of evidence): LD50 > 5000 mg/kg bw, 2018

1. Acute Dermal Toxicity (Read-Across: undec-9-enal): LD50 > 5000 mg/kg bw, eq. or similar to OECD TG 402, 1977

2. Absence of systemic toxicity in other oral and dermal toxicity studies meeting GHS/EU criteria

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1971
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP study following a method similar to a recognised guideline. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included in attachment to IUCLID section 13.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is based on the hypothesis that the source and target substances have common structural features in the same relative positions. The source and target have similar physico-chemical, toxicological properties and because of common metabolism they share common or have similar breakdown products and therefore potential mechanisms of action. Further information is included in attachment to IUCLID section 13.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable chemical similarity. Further information is included in attachment to IUCLID section 13

3. ANALOGUE APPROACH JUSTIFICATION
The source substance is a chemically similar substance with common metabolism and common or similar degradants of the target substance. Further information is included in attachment to IUCLID section 13

4. DATA MATRIX
Further information is included in attachment to IUCLID section 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150 - 300 g
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: derived from the initial screening study.
Doses:
5000 mg/kg
No. of animals per sex per dose:
screening study: 2main test: 8
Control animals:
no
Details on study design:
Initially two rats (fasted overnight) were used for screening purposes. They were given a single dose of 5 ml. or 5000 mg/kg of body weight by gastric intubation. Following the dosing, the toxic signs and mortality were recorded at one and four hours and once daily thereafter for a total of 14 days. Where the results indicated the test compound to be relatively nontoxic. (i.e., no deaths occurred), a group of eight additional rats was given the same dose via the same route. Following the above primary screening studies, the LD50 value was determined if one or two animals died within 48 hours in the initial screening (i.e., the first pair of animals) or if the incidence of death was greater than two of the total of 10 rats within the 14-day observation period. The LD50 value was determined using six groups of rats (five rats per group fasted overnight) by giving graded dosage levels of the test compounds via the same route. Toxic signs and mortality were recorded immediately following dosing and once daily thereafter for 14 days. The LD50 value was calculated according to Horn's method. A gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality was observed
Clinical signs:
diarrhoea, depression, salivation
Body weight:
not reported
Gross pathology:
no gross findings
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
For the target substance: the acute oral LD50 is > 5000 mg/kg.
Executive summary:

The study was performed on a source substance to assess the acute oral toxicity of the test material in the Sprague Dawley strain of rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, once only by gavage. A screening study was performed with 2 test animals to determine the dose used in the main test. In the main test, 8 test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. There were no deaths but clinical effects observed were diarrhoea, depression and salivation. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was estimated to be greater than 5000 mg/kg bodyweight.

The target substance is expected to have and acute oral LD50 of > 5000 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1971
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP study following a method similar to a recognised guideline. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150 - 300 g
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: derived from the initial screening study.
Doses:
5000 mg/kg
No. of animals per sex per dose:
screening study: 2main test: 8
Control animals:
no
Details on study design:
Initially two rats (fasted overnight) were used for screening purposes. They were given a single dose of 5 ml. or 5000 mg/kg of body weight by gastric intubation. Following the dosing, the toxic signs and mortality were recorded at one and four hours and once daily thereafter for a total of 14 days. Where the results indicated the test compound to be relatively nontoxic. (i.e., no deaths occurred), a group of eight additional rats was given the same dose via the same route. Following the above primary screening studies, the LD50 value was determined if one or two animals died within 48 hours in the initial screening (i.e., the first pair of animals) or if the incidence of death was greater than two of the total of 10 rats within the 14-day observation period. The LD50 value was determined using six groups of rats (five rats per group fasted overnight) by giving graded dosage levels of the test compounds via the same route. Toxic signs and mortality were recorded immediately following dosing and once daily thereafter for 14 days. The LD50 value was calculated according to Horn's method. A gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality was observed
Clinical signs:
diarrhoea, depression, salivation
Body weight:
not reported
Gross pathology:
no gross findings
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the acute oral LD50 of the test item is > 5000 mg/kg.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague Dawley strain of rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, once only by gavage. A screening study was performed with 2 test animals to determine the dose used in the main test. In the main test, 8 test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. There were no deaths but clinical effects observed were diarrhoea, depression and salivation. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was estimated to be greater than 5000 mg/kg bodyweight.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP Study following a method equivalent to a recognised guideline at a limit does, with some deviations not expected to affect the reliability of the study. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included in attachment to IUCLID section 13.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is based on the hypothesis that the source and target substances have common structural features in the same relative positions. The source and target have similar physico-chemical, toxicological properties and because of common metabolism they share common or have similar breakdown products and therefore potential mechanisms of action. Further information is included in attachment to IUCLID section 13.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable chemical similarity. Further information is included in attachment to IUCLID section 13

3. ANALOGUE APPROACH JUSTIFICATION
The source substance is a chemically similar substance with common metabolism and common or similar degradants of the target substance. Further information is included in attachment to IUCLID section 13

4. DATA MATRIX
Further information is included in attachment to IUCLID section 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
5 g/kg
No. of animals per sex per dose:
10 rabbits
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal reactions appear to be scored at 24 hours by the Draize scoring system. The rats were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in survivors at 14 days.
- Necropsy of survivors performed: Yes.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: n = 10
Mortality:
No mortalities.
Clinical signs:
Diarrhea was observed
Body weight:
Not reported.
Gross pathology:
In rat #3 of 10 - dark kidney. No other significant findings reported.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
For the target substance: the acute oral LD50 is > 5000 mg/kg.
Executive summary:

The study was performed on a source substance to assess the acute oral toxicity of the test material in the rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally. In the test, 10 test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. There were no mortalities but clinical effects observed were diarrhoea only. The acute oral median lethal dose (LD50) of the test material in the rat was estimated to be greater than 5000 mg/kg bodyweight.

The target substance is expected to have and acute oral LD50 of > 5000 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP Study following a method equivalent to a recognised guideline at a limit does, with some deviations not expected to affect the reliability of the study. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.
Reason / purpose:
read-across: supporting information
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
5 g/kg
No. of animals per sex per dose:
10 rabbits
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal reactions appear to be scored at 24 hours by the Draize scoring system. The rats were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in survivors at 14 days.
- Necropsy of survivors performed: Yes.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: n = 10
Mortality:
No mortalities.
Clinical signs:
Diarrhea was observed
Body weight:
Not reported.
Gross pathology:
In rat #3 of 10 - dark kidney. No other significant findings reported.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the acute oral LD50 of the test item is > 5000 mg/kg.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally. In the test, 10 test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. There were no mortalities but clinical effects observed were diarrhoea only. The acute oral median lethal dose (LD50) of the test material in the rat was estimated to be greater than 5000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
The available information as a whole meets the tonnage driven information requirements of REACH.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP study following a method equivalent to a recognised guideline at a limit dose, with some deviations not expected to affect the reliability of the study. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included in attachment to IUCLID section 13.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is based on the hypothesis that the source and target substances have common structural features in the same relative positions. The source and target have similar physico-chemical, toxicological properties and because of common metabolism they share common or have similar breakdown products and therefore potential mechanisms of action. Further information is included in attachment to IUCLID section 13.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable chemical similarity. Further information is included in attachment to IUCLID section 13

3. ANALOGUE APPROACH JUSTIFICATION
The source substance is a chemically similar substance with common metabolism and common or similar degradants of the target substance. Further information is included in attachment to IUCLID section 13

4. DATA MATRIX
Further information is included in attachment to IUCLID section 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Limit dose of 5000mg/kg bw applied single dose; gross pathology completed.
Principles of method if other than guideline:
The principles of the method were in accordance with the US 16 CFR 1500.3 definitions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: Not reported.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
Duration of exposure:
24h
Doses:
5000 mg/kg
No. of animals per sex per dose:
Not reported
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal reactions appear to be scored at 24 hours by the Draize scoring system. The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in survivors at 14 days
.- Necropsy of survivors performed: Yes.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities at the 5000 mg/kg bw limit dose.
Clinical signs:
None reported. No regrowth of hair at application site during the course of the 14 day observation period.
Body weight:
Not reported.
Gross pathology:
White thin walled areas of intestines in 2/10 rabbits; white area in outer surface of liver in 2/10 rabbits. White nodules in liver 1/10 rabbits.
Other findings:
Redness: 2/10 rabbits = mild redness (Score = 1) ; 6/10 rabbits = moderate skin irritation (score = 3) ; 1/10 rabbits severe (score = 4)Edema: 10/10 rabbits = moderate (score = 3)
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
For the target substance: the dermal LD50 was determined to be > 5000 mg/kg. The substance is expected to produce positive local irritation responses at the dose level employed.
Executive summary:

The pre-GLP study was performed on a source substance following a method similar to OECD 402 to assess the dermal toxicity of the test material to the rabbit. The test substance was evaluated in 10 rabbits. A dose of 5000 mg/kg test substance (undiluted), was applied for 24 hours. Skin observations were made 24 hours after patch removal and then daily for 14 days for signs of toxicity, pharmacological effects and mortality. No mortalities were observed. Very slight to well defined erythema and moderate edema were noted at 24 hours in all animals. Under the conditions of this study the LD50 is considered to be greater than 5000 mg/kg.

The target substance is expected to have and acute dermal LD50 of > 5000 mg/kg.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP study following a method equivalent to a recognised guideline at a limit dose, with some deviations not expected to affect the reliability of the study. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.
Reason / purpose:
read-across: supporting information
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Limit dose of 5000mg/kg bw applied single dose; gross pathology completed.
Principles of method if other than guideline:
The principles of the method were in accordance with the US 16 CFR 1500.3 definitions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: Not reported.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
Duration of exposure:
24h
Doses:
5000 mg/kg
No. of animals per sex per dose:
Not reported
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal reactions appear to be scored at 24 hours by the Draize scoring system. The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in survivors at 14 days.
- Necropsy of survivors performed: Yes.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities at the 5000 mg/kg bw limit dose.
Clinical signs:
None reported. No regrowth of hair at application site during the course of the 14 day observation period.
Body weight:
Not reported.
Gross pathology:
White thin walled areas of intestines in 2/10 rabbits; white area in outer surface of liver in 2/10 rabbits.
White nodules in liver 1/10 rabbits.
Other findings:
Redness: 2/10 rabbits = mild redness (Score = 1) ; 6/10 rabbits = moderate skin irritation (score = 3) ; 1/10 rabbits severe (score = 4)
Edema: 10/10 rabbits = moderate (score = 3)
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the dermal LD50 was determined to be > 5000 mg/kg. The test item is not considerd to be toxic to rabbits via the dermal route. The substance produced positive local irritation responses at the dose level employed.
Executive summary:

The pre-GLP study was performed following a method similar to OECD 402 to assess the dermal toxicity of the test material to the rabbit. The test substance was evaluated in 10 rabbits. A dose of 5000 mg/kg test substance (undiluted), was applied for 24 hours. Skin observations were made 24 hours after patch removal and then daily for 14 days for signs of toxicity, pharmacological effects and mortality. No mortalities were observed. Very slight to well defined erythema and moderate edema were noted at 24 hours in all animals. Under the conditions of this study the LD50 is considered to be greater than 5000 mg/kg.

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.5 (as amended by Commission Regulation (EU) 2016/863) the acute dermal toxicity (OECD TG 402) study does not need to be conducted based on an available for at least one additional route. In accordance with REACH Regulation (EC) No. 1907/2006 Annex XI: section 1.2 – weight of evidence, based on data on constituent substances (analogues). The available data via the oral route and its weight of evidence indicates that the acute oral toxicity LD50 > 5000 mg/kg bw. This is matched by available data on constituent substances (analogues) via the dermal route with an acute dermal toxicity LD50 > 5000 mg/kg bw. There is an absence of systemic toxicity in available Skin Sensitisation tests (OECD TG 429) and in acute dermal irritation tests (eq. or similar to OECD TG 404) on constituent substances. This indicates a clear weight of evidence that the EU criteria (Acute Toxicity and STOT-SE) will not been met. Toxicity via the dermal route is not envisaged. Further testing is not scientifically justified. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.4, July 2017) the study does not need to be conducted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
The available information as a whole meets the tonnage driven information requirements of REACH.

Additional information

Acute Oral Toxicity:

1. Eq. to OECD 401, 1971: Read-Across SOURCE (undec-10-enal): The study was performed to assess the acute oral toxicity of the test material in the Sprague Dawley strain of rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, once only by gavage. A screening study was performed with 2 test animals to determine the dose used in the main test. In the main test, 8 test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. There were no deaths but clinical effects observed were diarrhoea, depression and salivation. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was estimated to be greater than 5000 mg/kg bodyweight.

2. Eq. to OECD 401, 1977: Read-Across SOURCE (undec-9-enal): The study was performed to assess the acute oral toxicity of the test material in the rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally. In the test, 10 test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. There were no mortalities but clinical effects observed were diarrhoea only. The acute oral median lethal dose (LD50) of the test material in the rat was estimated to be greater than 5000 mg/kg bodyweight.

 

Acute Dermal Toxicity:

1. Eq. to OECD 402, 1977: Read-Across SOURCE (undec-9-enal): The pre-GLP study was performed following a method similar to OECD 402 to assess the dermal toxicity of the test material to the rabbit. The test substance was evaluated in 10 rabbits. A dose of 5000 mg/kg test substance (undiluted), was applied for 24 hours. Skin observations were made 24 hours after patch removal and then daily for 14 days for signs of toxicity, pharmacological effects and mortality. No mortalities were observed. Very slight to well defined erythema and moderate edema were noted at 24 hours in all animals. Under the conditions of this study the LD50 is considered to be greater than 5000 mg/kg.

2. In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.5 (as amended by Commission Regulation (EU) 2016/863) the acute dermal toxicity (OECD TG 402) study does not need to be conducted based on an available for at least one additional route. In accordance with REACH Regulation (EC) No. 1907/2006 Annex XI: section 1.2 – weight of evidence, based on data on constituent substances (analogues). The available data via the oral route and its weight of evidence indicates that the acute oral toxicity LD50 > 5000 mg/kg bw. This is matched by available data on constituent substances (analogues) via the dermal route with an acute dermal toxicity LD50 > 5000 mg/kg bw. There is an absence of systemic toxicity in available Skin Sensitisation tests (OECD TG 429) and in acute dermal irritation tests (eq. or similar to OECD TG 404) on constituent substances. This indicates a clear weight of evidence that the EU criteria (Acute Toxicity and STOT-SE) will not been met. Toxicity via the dermal route is not envisaged. Further testing is not scientifically justified. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.4, July 2017) the study does not need to be conducted.

Acute Inhalation Toxicity:

In accordance with REACH Regulation (EC) No. 1907/2006 Annex VIII, column 2 section 8.5 (as amended by Commission Regulation (EU) 2016/863) the acute inhalation toxicity (OECD TG 436/433 or OECD TG 403) study does not need to be conducted based on an available for at least one additional route. There is an acute oral toxicity and an acute dermal toxicity study available indicating a weight of evidence that the EU criteria has not been met. Toxicity via the inhalation route is not envisaged and the test item is not a skin corrosive. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.4, July 2017) the study does not need to be conducted.

Justification for classification or non-classification

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.

 

The weight of evidence based on read-across to constituent substances; via the oral and dermal routes indicates that the substance cannot be expected to produce acute toxicity sufficient for classification and labelling under the EU criteria. There is no evidence of significant systemic toxicity and no mortalities were observed. Therefore toxicity at category 4 acute toxicity is by expert judgement not supported.