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Administrative data

Description of key information

Disazocondensation red pigments were found to non toxic upon acute oral toxicity testing in rat with doses being tested in the range of 2000 and 10000 mg/kg bw. They are non toxic upon acute skin contact based on experimental data with Pigment Red 144 obtained with rabbits and based on the physico-chemical properties which indicate absent or very low skin permeability.  

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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: HanIbm: WIST
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., CH-4414 Füllinsdorf
- Age at study initiation: 8 weeks (males) and 10 weeks (females)
- Weight at study initiation: males: 193 - 210 g, females: 167 - 184 g
- Fasting period before study: overnight
- Housing: Groups of five
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: October 30 to November 13, 1991
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 ml


MAXIMUM DOSE VOLUME APPLIED: 10 ml

Doses:
2000 mg/kg bw
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 and weighing: Body weight on test days 1 (pre-administration), 8 and 15. Clinical signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and daily during days 2-15.
- Necropsy of survivors performed: yes
:
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred.
Mortality:
None
Clinical signs:
None
Body weight:
not affected
Gross pathology:
No findings
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions (TS purity unspecified; 30 mL test preparation per kg bw; 8 days observation period, individual test results missing, no data on necropsy)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
30 mL test preparation per kg bw; 8 days observation period, individual test results missing, no data on necropsy
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: CFE (RAC; SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeder; random breed
- Age at study initiation: young
- Weight at study initiation: 107-147 g
- Housing: in groups of 5 in macrolon cages (size 3)
- Diet (e.g. ad libitum): Nafag, ad lib.
- Water (e.g. ad libitum): drinking water, ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-1
- Humidity (%): 55+-5
- Photoperiod (hrs dark / hrs light): 10/14
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous suspension with 0.5% CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25/ 33.3%

MAXIMUM DOSE VOLUME APPLIED: 30 mL/kg bw
Doses:
5000 and 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: observations: no data; weighing at day 0 and day 8
- Necropsy of survivors performed: not reported
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: only unspecific clinical signs observed
Mortality:
not observed
Clinical signs:
5000 mg/kg bw: piloerection
10000 mg/kg bw: ataxia, sedation, piloerection, inhibition of spontaneous motility, red stained urine and feces
Body weight:
Mean weights
5000 mg/kg bw: day 0: 140 g; day 8: 187 g
10000 mg/kg bw: day 0: 112 g; day 8: 170 g
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD Guideline 401; no GLP)
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Version August 6, 1987
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: albino rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RAIf (SPF) hybrids (of RII/1 x RII/2) rats from Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 204-236 g
- Fasting period before study: overnight prior to dosing
- Housing: caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS (the animal room was air conditioned)
- Temperature (°C): 22±3°C
- Humidity (%): 55±15%
- Air changes (per hr): approx. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL

MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg bw
Doses:
5000 mg/kg bw
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 and weighing: mortality twice on working days and once on weekend days; signs and symptoms daily; body weight at start and on days 7 and 14
- Necropsy of survivors performed: yes; at the end of the observation period
Statistics:
From the body weights, the group means and their standard deviations were calculated
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed at this unique dose level
Mortality:
No mortality occurred
Clinical signs:
- Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests.
- Additionally, a red discoloration of the body was observed from day 1 to 4 after administration.
- The animals recovered within 11 days.
Body weight:
No adverse effects observed (see Table 1)
Gross pathology:
No deviations from normal morphology were found at necropsy

Table 1: Mean body weights (g) and standard deviation

Dose level (mg/kg bw)

Males

Females

Day 1

Day 7

Day 14

Day 1

Day 7

Day 14

5000

227±6.2

265±7.4

306±7.6

212±7.5

211±13.7

224±14.3

 

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: only unspecific clinical signs observed
Mortality:
not observed
Clinical signs:
5000 mg/kg bw: piloerection
10000 mg/kg bw: ataxia, sedation, piloerection, inhibition of spontaneous motility, red stained urine and feces
Body weight:
Mean weights
5000 mg/kg bw: day 0: 140 g; day 8: 187 g
10000 mg/kg bw: day 0: 112 g; day 8: 170 g
Interpretation of results:
GHS criteria not met
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed at this unique dose level
Mortality:
No mortality occurred
Clinical signs:
- Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests.
- Additionally, a red discoloration of the body was observed from day 1 to 4 after administration.
- The animals recovered within 11 days.
Body weight:
No adverse effects observed (see Table 1)
Gross pathology:
No deviations from normal morphology were found at necropsy

Table 1: Mean body weights (g) and standard deviation

Dose level (mg/kg bw)

Males

Females

Day 1

Day 7

Day 14

Day 1

Day 7

Day 14

5000

227±6.2

265±7.4

306±7.6

212±7.5

211±13.7

224±14.3

 

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Limit test:
yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred.
Mortality:
None
Clinical signs:
None
Body weight:
not affected
Gross pathology:
No findings
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Reliable and valid.

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Unreliable testing facility: study protocol equivalent or similar to OECD Guideline 403 (TS concentration in testing atmosphere <5 mg/l, no MMAD / GSD, whole body exposure, no details on analytical verification of test atmosphere concentration, body weight determined only twice [start and end]; TS purity not specified; no GLP)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
Dust
Deviations:
yes
Remarks:
TS concentration in testing atmosphere <5 mg/l, no MMAD / GSD, whole body exposure, no details on analytical verification of test atmosphere concentration, body weight determined only twice [start and end]; TS purity not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ARS/Sprague-Dawley, Madison, Wisconsin
- Age at study initiation: no data (young albino rats)
- Weight at study initiation: 205
- Housing: housed in stock cages
- Diet (e.g. ad libitum): standard laboratory diet (Purina Rat Chow, Ralston Purina Company, St. Louis, Missouri); ad libitum, except during inhalation exposure
- Water (e.g. ad libitum): drinking water; ad libitum , except during inhalation exposure
- Acclimation period: at leat 5 days

ENVIRONMENTAL CONDITIONS
No data
Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: test animals were exposed in a specially constructed Plexiglas inhalation chamber. The chamber was designed so that the animals could be introduced to the test atmosphere after the maximum dust concentration was established.
- Exposure chamber volume: 70 liters
- Method of holding animals in test chamber: not further specified; each animal was caged separately during exposure to minimize filtration of inspired air by animal fur.
- Source and rate of air: air flow rate through the system was 4.1 L/min at 29.92 inches Hg and 25°C (measured with a rotameter connected upstream of the dust feeder). The rotameter was calibrated with a wet-test meter after the exposure was completed.
- System of generating particulates/aerosols: dust was suspended with a specially designed dust feeder capable of producing high concentrations over a long period of time. The test material powder was passed through a high-velocity stream of clean dry air (-40°C dewpoint). The resulting air and dust mixture was then introduced into the exposure chamber at the top center, dispersed by a baffle plate and exhausted at the bottom of the chamber.
- Method of particle size determination: a sample of airborne dust was collected from the test atmosphere for the purpose of conducting a microscopic determination of particle size distribution. Particles were counted with respect to three size ranges, viz. 5 µm or smaller (considered to be respirable), 6-25 µm and >25 µm. The smallest particle which can be detected by the light-field technique employed is approximately µm. The largest particle observed was also recorded.
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: the temperature of the test atmosphere was 22.5°C and the pressure was 30.50 inches Hg.

TEST ATMOSPHERE
- Brief description of analytical method used: the concentration of test material dust present in the exposure chamber was determined by sampling the test atmosphere in the breathing zone of the animals being exposed. The total weight of dust collected on a glass fiber filter was divided by the total volume of air drawn through the filter during the sampling period. Air flow rate for sampling was regulated by a calibrated limiting orifice. The average concentration of airborne dust, obtained by repeated air sampling, was 2200 mg/m3 air at 25°C and 29.92 inches Hg.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Table 1
Analytical verification of test atmosphere concentrations:
not specified
Remarks:
not specified
Duration of exposure:
4 h
Concentrations:
2200 mg/m3
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 and weighing: initial and final body weights and reactions were recorded; the exposure was designed to run for a 4-hour period, during which time observations were made with respect to incidence of mortality and reactions displayed. At the end of the exposure period, the rats were returned to their stock cages and observed for the following 14 days.
- Necropsy of survivors performed: yes, gross pathologic examinations were scheduled to be conducted upon all animals which might succumb during the test period and upon those sacrificed at the end of the 14-day observation period.
Statistics:
In the event of significant mortality following the initial exposure, arrangements were made to conduct additional experiments at lower dust concentrations in order to acquire data sufficient to calculate the acute dust inhalation median lethal concentration (LC50) of the test material employing the method of Litchfield and Wilcoxon.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 200 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No deaths were noted during the four-hour exposure period or 14-day observation period which followed
Mortality:
No deaths were noted during the four-hour exposure period or 14-day observation period which followed.
Clinical signs:
other: No abnormal behavioral reactions were noted during the four-hour exposure period or 14-day observation period which followed.
Body weight:
Some animals lost weight and the average body weight gain was slightly lower than historical control data (Table 1).
Gross pathology:
Necropsy, performed on all animals at the end of the two-week observation period, revealed slight to moderate diffuse focal red discoloration of the lungs in six rats. There were no other gross pathologic alterations in any of the other tissues and organs examined.

Table 2: Body weight data

Animal number and sex

Individual and mean body weights and body weight gain (g)

Body weights (g) after

14-day body weight gain

0 day

14 days

1-Male

241

234

-7

2-Male

221

249

28

3-Male

236

262

26

4-Male

228

223

-5

5-Male

223

231

8

Mean

230

240

10

1-Female

187

210

23

2-Female

185

174

-11

3-Female

175

170

-5

4-Female

179

174

-5

5-Female

175

195

20

Mean

180

185

4

Historical control data: the average 14-day body weight gain for a group of rats equally sexed and weighing 175 to 225 grams is approximately 25 to 35 grams.

 

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Duration of exposure:
h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 200 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No deaths were noted during the four-hour exposure period or 14-day observation period which followed
Mortality:
No deaths were noted during the four-hour exposure period or 14-day observation period which followed.
Clinical signs:
other: No abnormal behavioral reactions were noted during the four-hour exposure period or 14-day observation period which followed.
Body weight:
Some animals lost weight and the average body weight gain was slightly lower than historical control data (Table 1).
Gross pathology:
Necropsy, performed on all animals at the end of the two-week observation period, revealed slight to moderate diffuse focal red discoloration of the lungs in six rats. There were no other gross pathologic alterations in any of the other tissues and organs examined.
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (TS purity not specified; size of application area not reported; 4 animals used (without justification); abraded skin was treated in 2 animals)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
4 animals used (without justification); abraded skin was treated in 2 animals; size of application area not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: local supplier
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in elevated wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad lib.
- Water (e.g. ad libitum): water from bottles ad lib.
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Housing in temperature controlled rooms (no further details)
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back, intact or abraded skin (each 2 animals; abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did not disturb the derma or produce bleeding)
- % coverage: not reported (regarding the body weight of ca. 2500 mg and the formula BSA = 9.5 * (body weight in g)exp(2/3), the test site should be > 180 cm2 for guideline conformity)
- Type of wrap if used: impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water

TEST MATERIAL
- Concentration (if solution): 50% w/v suspension in distilled water
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once daily; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: evaluation of local effects according to OECD Draize scheme after 25 hours, 7 and 14 days
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Abrasion (2/4 animals) had no effect on local or systemic effects
Mortality:
no mortality
Clinical signs:
in 1 animal (intact skin): Diarrhea, days 3 & 4 and 7 to 10; Abdomen bloated, days 4 to 7; Anorexia, days 5 and 6; Adipsia, days 5 and 6; no fecal matter in pan day 5.
Body weight:
Body weight gain was inconsistent in the four animals (slight loss of weight in 2 animals in the first week and in a third animal in the second week; constant weight gain in the 4th animal). Since no data of control animals were available, a treatment effect cannot be excluded but is considered as unlikely.
Gross pathology:
One animal had yellow exudate from nose/mouth and another had bloated intestines. No abnormal findings in the other two animals (with abraded skin).
Other findings:
Neither erythema nor edema were observed.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Abrasion (2/4 animals) had no effect on local or systemic effects
Mortality:
no mortality
Clinical signs:
in 1 animal (intact skin): Diarrhea, days 3 & 4 and 7 to 10; Abdomen bloated, days 4 to 7; Anorexia, days 5 and 6; Adipsia, days 5 and 6; no fecal matter in pan day 5.
Body weight:
Body weight gain was inconsistent in the four animals (slight loss of weight in 2 animals in the first week and in a third animal in the second week; constant weight gain in the 4th animal). Since no data of control animals were available, a treatment effect cannot be excluded but is considered as unlikely.
Gross pathology:
One animal had yellow exudate from nose/mouth and another had bloated intestines. No abnormal findings in the other two animals (with abraded skin).
Other findings:
Neither erythema nor edema were observed.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.