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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 402: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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): Exxal 13
- Physical state: colorless liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: 11 – 13 weeks
- Weight at study initiation: male (233-268 g), female (187-205 g)
- Housing: individually
- Diet (e.g. ad libitum): Kliba 343, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- 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: backs
- % coverage: 10
- Type of wrap if used: occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tape water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml at 2000 mg/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
No data analyzed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: All animals survived
Mortality:
All animals survived
Clinical signs:
Slight erythema observed within 24 hours of exposure. Resovled by 4 days post exposure.
Body weight:
No findings noted.
Gross pathology:
No findings noted.
Other findings:
No findings noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for isotridecanol is greater than 2000 mg/kg.
Executive summary:

In this study, 10 rats were exposure to 2000 mg/kg body weight of isotridecanol via an occluded dermal patch for 24 hours to assess acute toxicity.  Clinical observations were made at 1, 2, 3, 5, and 24 hours and daily thereafter for 14 days.  All animals survived the exposure. It is concluded that the LD50 is greater than 2000 mg/kg.