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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
It was not compliant with GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: IFFA CREDO

- Weight at study initiation: 180-200g

- Housing: in individual cages (37.5x17x15 cm)

- Diet: IFFARAT feed, ad libitum

- Water: ad libitum



ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 +/- 1C

- Humidity (%): 50 +/- 10

- Air changes (per hr): 8



IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: shaved dorsal skin

- Type of wrap if used: an aluminium sheet, held in place with adhesive tape


REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed



TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.62 ml/kg



Duration of exposure:
Single application, not rinsed
Doses:
2000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days


Statistics:
No statistical analysis reported in the study report.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the study.
Clinical signs:
No skin reactions were noted during the exposure or over the 14 day observation period.
Body weight:
No test substance adverse effects on body weight were reported.
Gross pathology:
Not reported.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal LD50 value of >2000 mg/kg was determined for male and female rats in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.