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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
12 Mar - 26 Mar 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions. Lack of test material details.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
lack of test material details
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): only trade name given
- Batch No.: 4026-3
- Physical state: pellets
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 179 g (males) and 143 g (females)
- Housing: animals were housed individually in Makrolon cages type II with soft wood bedding
- Diet: Altromin 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 51
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 cm x 4 cm clipped skin of the dorsal area of the trunk
- Type of wrap if used: The test material was held in contact with the skin with gauze and polyethylene sheet and leukosilk bandage and acrylastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was washed off
- Time after start of exposure: 24 h

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: several times on day of application, thereafter twice a day
- Frequency of observations and weighing: before administration and on Days 2, 7 and 14.
- Necropsy of survivors performed: yes, after 14 days from all treated animals
- Other examinations performed: daily skin examination

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:
No clinical signs were observed up to the end of the 14-day observation period.
Body weight:
Body weight gains were within the normal ranges in males and females during the whole study period.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings. One male and two female animals showed a reddening of the ileum mucosa, not treatment-related.
Other findings:
No local skin irritation 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