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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Test article: CGA 224443 tech.
- Batch No.: P. 810012
- Purity: 92,6%

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd. (Animal Production)
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 212 - 237 g
- Fasting period before study:
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding
- Diet (e.g. ad libitum): NAFAG 890 Tox and water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
PRETREATMENT
Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the bodysurface was shaved with an electric clipper.

APPLICATION
The required amount of the test substance was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly.
Duration of exposure:
24 hours
Doses:
One single dose
Dose level: 4000 mg/kg body weight
No. of animals per sex per dose:
dose group: 10 rats (5 males and 5 females)
Control animals:
no
Details on study design:
OBSERVATIONS AND RECORDS
- Observation period: 14 days
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
- Signs and symptoms: daily
- Body weight: immediately before application and on days 7 and 14
- Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Mortality:
No mortality occured in this study
Clinical signs:
Piloerection, abnormal body positions and dyspnea were seen, being common symptoms in acute dermal tests.
The animals recoverd within 5 days.
See attached Table 2
Body weight:
see attached Table 1

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information