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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Conducted prior to adoption of OECD test guidelines.
Deviations:
yes
Remarks:
Limited details on methods and animal conditions.
Principles of method if other than guideline:
Method: other: Not stated. Insufficient detail to fully assess comparability with OECD guideline.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: Males: 2.3-2.5 kg. Females: 2.0 and 2.1 kg.
- Fasting period before study: No data
- Housing: Individually (cage type to stated)
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: "plastic strips"


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 25% aqueous solution
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 25% solution
Duration of exposure:
24 hours
Doses:
1000, 1580, 2510, 3980 and 6310 mg/kg bw
No. of animals per sex per dose:
One
Control animals:
no
Details on study design:
- Duration of observation period following administration: Not clear, but at least five days.
- Frequency of observations and weighing: Body weights appear to have been measured prior to dosing and five days after dosing.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and gross pathology of animals that die.
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 310 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred at any dose.
Clinical signs:
Activity and appetite were temporarily reduced after doses of 3980 and 6310 mg/kg bw.
Body weight:
No apparent effects.
Gross pathology:
No deaths so not conducted.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a well conducted acute dermal study (reliability score 2), conducted according to a protocol similar to OECD 402, but not to GLP, a dermal LD50 of >6310 mg/kg bw was determined for ATMP-H (Dequest 2000) in the rabbit.
Executive summary:

In an acute dermal toxicity study conducted prior to the adoption of OECD test guidelines and GLP, Dequest 2000 was applied to the clipped, intact skin, under an occlusive dressing, for up to 24 hours, at doses of 1000, 1580, 2510, 3980 and 6310 mg/kg bw (one New Zealand white rabbit per dose). The animals were then observed for clinical signs of toxicity (no further details). There were no deaths and therefore no macroscopic examination was conducted. Activity and appetite were temporarily reduced in the two highest-dose animals. The LD50 was >6310 mg/kg bw.