Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-guideline and pre-GLP study. Only basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no details on test substance, test animals, environmental condition of animal room, body weight, pathology findings and method of LD50 calculation
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2-methoxy-4-prop-1-enylphenyl acetate
EC Number:
202-236-1
EC Name:
2-methoxy-4-prop-1-enylphenyl acetate
Cas Number:
93-29-8
IUPAC Name:
2-methoxy-4-prop-1-en-1-ylphenyl acetate
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
Duration of exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and mortality daily for 14 days.
- Necropsy of survivors performed: No data
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
- 1/10 animal died on Day 7 post exposure.
Clinical signs:
other: - 6/10 and 1/10 animals showed slight and moderate skin redness (erythema), respectively.
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance is not classified according to the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS since Rabbit Dermal LD50 > 5000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (limit test), skin of ten rabbits was exposed to test material at dose of 5000 mg/kg bw. Animals were observed for mortality and clinical signs daily for 14 days.

 

1/10 animal died on Day 7 post exposure. Slight and moderate skin redness (erythema) was observed in 6/10 and 1/10 animals, respectively.

 

Rabbit Dermal LD50 > 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS. 

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.