Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Mar - 10 Apr 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Y-11542
- Physical state: clear, colorless, slightly viscous liquid
- Lot/batch No.: 2131UG060495
- Storage conditions: original container at room temperature
- Stability under test and storage conditions: Test material stability data are the responsibility of
the Sponsor. Under the conditions employed during the testing of this material, the Sponsor has indicated that the material is stable, provided the sample is not contaminated, is properly sealed, and stored under normal conditions as dictated by good manufacturing practice.

Test animals

Species:
rat
Strain:
other: Crl:CD BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI, USA
- Age at study initiation: young adults
- Weight at study initiation: 242 - 295 g
- Housing: animals were housed individually in suspended mesh-bottom cages
- Diet: Purima Certified Rodent Chow #5002 diet, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9 - 22.3
- Humidity (%): 34.4 - 40.5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The test material was applied to the dorsal skin of each animal.
- % coverage: 18 - 23
- Type of wrap if used: The test substance was held in contact with the skin with gauze bandaging. The bandage was secured with nonirritating tape. Collars were applied and remained on the rats for the duration of the exposure to prevent the ingestion of the test material and/or wrappings during the 24 h exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: The application sites were wiped with disposable paper towels moistened with tepid tap water after the exposure period.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 1.75 ml/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at approximately 1, 3 and 4 hours post-exposure on day 0 and twice daily for mortality (morning and afternoon) and once daily for clinical observations thereafter for 14 days, respectively. Body weights were obtained and recorded on study days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: The application sites were examined for erythema, edema and other dermal findings beginning approximately 30 - 60 min after bandage removal and daily thereafter for 13 days. The areas of application were clipped free of hair to facilitate dermal observations on study days 7 and 14.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: neither erythema nor edema were observed
Mortality:
No deaths were observed during the study.
Clinical signs:
Clinical findings were limited to dried red material around the nose and/or forelimb(s) for three rats and wet and dried yellow urogenital staining for two female rats. These findings are typically noted in association with the bandage/collar application procedures and are not considered related to test material application. There were no other clinical findings. All animals appeared normal by day 3 or earlier and throughout the remainder of the study.
Body weight:
There were no remarkable changes or differences in body weights during the study period.
Gross pathology:
A dilated renal (right) pelvis was noted for one female rat at the terminal necropsy. This is considered to be a common, spontaneous finding in rats and was not considered to be related to the test material. There were no other gross necropsy findings for any examined tissues.
Other findings:
- Dermal observations: Six rats showed desquamation. Neither erythema nor edema or other dermal findings were recorded. All dermal responses completely subsided by day 13 or earlier.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no clinical signs of toxicity or mortalities were observed. Therefore, the test substance does not need to classified according to Regulation (EC) No 1272/2008.