Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Feb - 03 Mar 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 Feb 1987
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Version / remarks:
adopted 22 Sep 1988
Deviations:
no
Qualifier:
according to
Guideline:
other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 20 - 21), 1985
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Details on test animals and environmental conditions:
TEST ANIMALS
- Animal strain as specified by the author: WISKf(SPF71)
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: approx. 8 weeks (males), approx. 11 weeks (females)
- Weight at study initiation: 225 g (males), 227 g (females)
- Fasting period before study: no
- Housing: individually in Makrolon cages (Type 4) on soft wood granulate
- Diet: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: sesame oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 cm² shaved skin of the dorsal area of the trunk
- Type of wrap if used: The treated skin area was covered with a porous gauze and an aluminium foil (6x8 cm), which was held in place with an elastic plaster bandage fixed around the animal's body in order to avoid evaporation of the test substance and to ensure that the animals cannot ingest the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: yes, limit test
- For solids, paste formed: yes, with sesame oil (0.5 g test substance + 0.36 mL sesame oil)
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: 15 days
- Frequency of observations and weighing: animals were observed 15, 30, 60 min and 2, 4 and 6 h after dosing, twice daily from day 2 to 6 and daily thereafter until the end of the observation period, and individual body weights were determined weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Mean body weights and standard deviations were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
2000 mg/kg bw: 1/5 female animals showed alopecia and an encrusted skin surface on its rump. These findings, which did not affect the treated skin area, were considered as incidental non-adverse findings. No clinical signs of toxicity were observed up to the end of the 15-day observation period in the remaining 9 animals.
Body weight:
2000 mg/kg bw: Slightly impaired body weight gain was observed in 2/5 females until day 7, thereafter body weight gains were within the normal ranges.
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
No local effects on the treated skin area were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified