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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
other: Secondary Literature
Title:
SIDS Initial Assessment Profiles for test material
Author:
Organization for Economic Co-operation and Development,
Year:
2012
Bibliographic source:
SIDS Initial Assessment Profiles for test material ,2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To determine the acute dermal toxicity of the test chemical in rabbits.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chlorotoluene
EC Number:
203-397-0
EC Name:
4-chlorotoluene
Cas Number:
106-43-4
Molecular formula:
C7H7Cl
IUPAC Name:
1-chloro-4-methylbenzene
Test material form:
solid
Details on test material:
Name of the test chemical: Benzene, 1-chloro-4-methyl-
Molecular Formula: C7H7Cl
Molecular Weight: 126.585 g/mol
Substance Type: Organic
Physical State: Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: shaved (abraded and intact) back skin
- % coverage:
- Type of wrap if used: covered under occlusive conditions (gauze pad, rubber dam and several wrappings of Elastoplast)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: The test chemical was removed with a wet towel. pst exposure observation time 14 days
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days (or other?) : 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes/no : yes
- Clinical signs including body weight : yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: death and surviving animals were necropsied.
Statistics:
LD50 value was calculated according to the method of Weil (1952).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no death occurred;
Clinical signs:
1 animal suffered from diarrhea; all others were unremarkable
Body weight:
no data available
Gross pathology:
At necropsy, there were no remarkable findings in males whereas females showed dark red mottled lungs
Other findings:
skin reactions:
abraded skin:
-----male:
no erythema, no edema no atonia no desquamation, no fissuring and no
eschar formation
------female:
erythema: score: 1 from d3-13; d14 score 0
edema: score: 1 from d3-13; d14 score 0
atonia: score 1 from d6-8, score 2 from d9-10, score 1 d11-13; d14 score 0
Fissuring: score 1 from d5-7; score 2 d8-13; score 1 d14
Eschar formation from d9 onwards and from d11 exfoliation
intact skin:
-----male
Erythema from d10-14 score 1
edema from d4-14 score 1
atonia from d5-8 score 1; d9-12 score 2; d13-14 score 1
Desquamation from d13-14 score 1
Fissuring from d5-13 score 2; d14 score 1
Eschr formation fron d 9 onwards and exfoliation at d 14
-----female
no erythema
edema: from d4-9 score 1
atonia: from d7-9 score 1; d9-14 score 0
Desquamation: from d10-14 score 1
Fissuring: at d 5 score 2; d 6-11 score 1; from d 12 score 0
no eschar formation and no exfoliation

Applicant's summary and conclusion

Interpretation of results:
other: Not Classified
Conclusions:
No death occured throughout the observation period. At necropsy, there were no remarkable findings in males whereas females showed dark red mottled lungs.Hence, the acute dermal LD50 can be considered to be greater than 2000 mg/kg when the test chemical was applied to the skin of New Zealand White rabbits.
Executive summary:

Astudy was performed to determine the acute dermal LD50 of the test chemical. 2000 mg/kg bw undiluted test chemical was applied to shaved (abraded and intact) areas of the back of each of 2 New Zealand White rabbits/sex und covered under occlusive conditions (gauze pad, rubber dam and several wrappings of Elastoplast) for 24 hours. Afterwards the restrainer and wrappings were removed and the test chemical was removed with a wet towel. pst exposure observation time 14 days, death and surviving animals were necropsied. LD50 value was calculated according tzo the method of Weil (1952). No death occured throughout the observation period. At necropsy, there were no remarkable findings in males whereas females showed dark red mottled lungs.Hence, the acute dermal LD50 can be considered to be greater than 2000 mg/kg when the test chemical was applied to the skin of New Zealand White rabbits.