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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 43 FR 37336, Part 163.81-2
Principles of method if other than guideline:
The test article was applied to the clipped and abraded skin of 5 male and 5 female albino rabbits at a dose level of 2 grams per kg bw. the animals were observed for mortality, clinical signs and body weight gain. A gross necropsy was performed of all animals sacrifieced on day 14.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
EC Number:
616-466-9
Cas Number:
77501-63-4
Molecular formula:
C19H15ClF3NO7
IUPAC Name:
(2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
Test material form:
liquid: viscous
Details on test material:
very viscous, brown, oily liquid

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals were applied a dose of 2000 mg/kg bw
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

All animals survived the 14-day duration of the study.

One female gained body weihgt consistantly from day 0 to day 14. One male and one other female lost body weight from day 0 to day 7. The remaining 4 males and 3 females lost body weight from day 0 to day 7 and regained at least 40% of this lost body weight from day 7 to day 14.

Very slight and/or well defined erythema was observed for all animals from days 1 or 2 as late as day 11. No other dermal reactions were observed during the study.

Gross necropsy examinations revealed solitary or multiple, red or red-brown discolorations of the skin at the test sites of one male and 3 females. A diffuse, green discoloration of the lung was also observed upon necropsy examination of one ot these females. Necropsy examination of one other male revealed a solitary, tan depression on the stomach. No other abnormalities were observed upon necropsy examinations of all animals sacrificed on day 14.

Applicant's summary and conclusion

Executive summary:

The test article was applied to the clipped and abraded skin of 5 male and 5 female albino rabbits at a dose level of 2 grams per kg bw. the animals were observed for mortality, clinical signs and body weight gain. A gross necropsy was performed of all animals sacrifieced on day 14. All animals survived the 14-day duration of the study.

Therefore the LD50 is > 2000 mg(kg bw (rabbit, m+f)