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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
single dose level of 5000 mg/kg
No. of animals per sex per dose:
3 female
Control animals:
no
Details on study design:
Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
other: one animal briefly had dhiarrea on Day 0
Gross pathology:
none
Other findings:
none
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute oral LD50 in female rats was > 5000 mg/kg bw.
Executive summary:

A study was conducted to evaluate the acute oral toxicity of the test substance according to OECD Guideline 425, in compliance with GLP. Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology. All animals survived to study end. One animal briefly had diarrhoea on Day 0; there were no additional abnormal physical signs observed. Two animals gained weight and one animal lost weight between Days 7 and 14. The gross necropsy of all animals revealed no observable abnormalities. Under the study conditions, the acute oral LD50 in female rats was > 5000 mg/kg bw (Unnamed, 2012).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Adequate quality

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
22 Mar - 05 Apr 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Limited information on test substance and animal husbandry. Read across study.
Justification for type of information:
Based on its composition and physico chemical properties, fatty acids, C5-10, esters with pentaerythritol is considered to be a suitable read across substance to address the acute inhalation toxicity endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
(No details on test material and limited data on animal husbandry)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Alpk:APfSD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Alderly Park, Cheshire, UK
- Age at study initiation: approx. 7 weeks
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: dried and filtered air
- System of generating aerosols: glass concentric jet atomiser
- Method of particle size determination: Marple Cascade Impactor
- Temperature, humidity, pressure in air chamber: 20 L/min

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.51 µm/2.51
Analytical verification of test atmosphere concentrations:
yes
Remarks:
particulate concentrations of the test atmospheres close to the animals breathing zone were measured gravimetrically
Duration of exposure:
4 h
Concentrations:
5.0 mg/L (nominal)
5.10 mg/L (analytical)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for gross clinical abnormalities during exposure and were checked daily thereafter. A detailed examination was conducted after exposure on day 1 and on consecutive days, up to and including day 15. Individual body weights were recorded on Day 1 and Days 2, 3, 8 and day 15.
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.1 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.1 mg/L air.
Executive summary:

A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-10, esters with pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) to an aerosol of the test material with an analytical concentration of 5.10 mg/L air (nominal concentration was 5.0 mg/L) for an exposure duration of 4 h. No mortality occurred during the 14 day study period. Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for exposure. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.1 mg/L air (Parr-Dobrzanski, 1994).

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
22 Mar - 05 Apr 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Limited data on test substance. Read across study.
Justification for type of information:
Based on its composition and physico chemical properties, fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol is considered to be a suitable read across substance to address the acute inhalation toxicity endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Limited data on study substance
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Alpk:APfSD
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Not stated
- Source and rate of air: 20 L/min using a peristaltic pump
- Method of conditioning air: Clean dry air (dried and filtered, no further details)
- System of generating particulates/aerosols: Glass concentric jet atomiser
- Method of particle size determination: Marple Cascade Impactor

TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetrical measurement
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: No Data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.76 µm / 2.35 µm
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gravimetrically measurement of particulate concentrations
Duration of exposure:
4 h
Concentrations:
5 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: on Days 1, 2, 3, 8 and 15
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: Clinical signs seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although, hunched posture and
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.0 mg/L air.
Executive summary:

A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) for 4 h to an aerosol of the test substance with an analytical concentration of 5.0 mg/L air. No mortality occurred during the 14 d study period. Clinical signs were seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although hunched posture and piloerection persisted in a few animals to Days 4 and 8, respectively. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.0 mg/L air (Parr-Dobrzanski, 1994).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
0.005 mg/m³ air
Quality of whole database:
Adequate quality

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
05 Jan - 19 Jan 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Limited data on test substance. Read across study.
Justification for type of information:
Based on its composition and physico chemical properties, 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid is considered to be a suitable read across substance to address the acute dermal toxicity endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
limited data on test substance
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
limited data on test substance
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males: 202 - 217 g (male) and 202 - 212 g (female)
- Housing: individually housed in suspended polypropylene cages for the time of exposure and in groups of five, by sex, for the reminder of the study.
- Diet: ad libitum, Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, UK
- Water: ad libitum
- Acclimation period: minimum 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 (18 at one ocasion, this was not considered relevant for the study)
- Humidity (%): 47-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% of total body surface
- Type of wrap if used: gauze secured with self adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with cotton wool moistened with distilled water
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5 h; 1 h; 2 h and 4 h after dosing and daily thereafter for 14 days. Weighing on Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Skin reactions according to Draize Scoring System (1977)
Statistics:
Not required
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute dermal LD50 in male and female rats was> 2000 mg/kg bw.
Executive summary:

A study was conducted to evaluate the acute inhalation toxicity of the read across substance, 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid, according to OECD Guideline 402, in compliance with GLP. The back and flanks regions of five male and female Sprague Dawley rats was treated with 2000 mg/kg bw under semiocclusive conditions. Twenty four hours after dosing, the treated area of skin was cleaned with distilled water and cotton wool. No mortality occurred and no clinical signs of toxicity were observed in any of the animals during the 14 d observation period. The test substance had no effect on bodyweight. Necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute dermal LD50 in male and female rats was> 2000 mg/kg bw (Allen, 1999).

Endpoint conclusion
Endpoint conclusion:
no study available
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Adequate quality

Additional information

Oral

A study was conducted to evaluate the acute oral toxicity of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to OECD Guideline 425, in compliance with GLP. Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology. All animals survived to study end. One animal briefly had diarrhoea on Day 0; there were no additional abnormal physical signs observed. Two animals gained weight and one animal lost weight between Days 7 and 14. The gross necropsy of all animals revealed no observable abnormalities. Under the study conditions, the acute oral LD50 in rats was > 5000 mg/kg bw (Unnamed, 2012).

Inhalation

Study 1:

A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) for 4 h to an aerosol of the test substance with an analytical concentration of 5.0 mg/L air. No mortality occurred during the 14 d study period. Clinical signs were seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although hunched posture and piloerection persisted in a few animals to Days 4 and 8, respectively. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.0 mg/L air (Parr-Dobrzanski, 1994).

Study 2:

A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-10, esters with pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) to an aerosol of the test material with an analytical concentration of 5.10 mg/L air (nominal concentration was 5.0 mg/L) for an exposure duration of 4 h. No mortality occurred during the 14 day study period. Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for exposure. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.1 mg/L air (Parr-Dobrzanski, 1994).

Dermal

A study was conducted to evaluate the acute inhalation toxicity of the read across substance, 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid, according to OECD Guideline 402, in compliance with GLP. The back and flanks regions of five male and female Sprague Dawley rats was treated with 2000 mg/kg bw under semiocclusive conditions. Twenty four hours after dosing, the treated area of skin was cleaned with distilled water and cotton wool. No mortality occurred and no clinical signs of toxicity were observed in any of the animals during the 14 d observation period. The test substance had no effect on bodyweight. Necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute dermal LD50 in male and female rats was> 2000 mg/kg bw (Allen, 1999).

Justification for classification or non-classification

Based on the results of studies with appropriate read across substances, the test substance does not require classification for acute toxicity according to EU CLP (EC 1272/2008) criteria.