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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:
03.08.1982 to 17.08.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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)
Principles of method if other than guideline:
Method: other: Safepharm protocol (number GM 08/82/53A)
GLP compliance:
yes
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: A. Tuck & Sons Limited, Essex, UK.
- Age at study initiation: 6-8 weeks
- Weight at study initiation: Males: 219-242 g: Females: 210-232 g.
- Fasting period before study: None
- Housing: Five per polypropylene cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 65-75
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 03.08.1982 to 17.08.1982

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal, lateral and ventral.
- % coverage: No data
- Type of wrap if used: The trunks of the rats were encircled with a strip of elastic adhesive bandage, backed with aluminium foil. The bandage was tightened sufficiently to prevent the animal from wriggling free and wrapped round to form a double layer.


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
10 ml/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2, 3, 4 and 5 hours following dosing. On subsequent days the animals were observed at least once. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
None required.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: presumed equivalent to >5740 mg active salt/kg bw
Mortality:
No animals died.
Clinical signs:
Lethargy and increased red coloured lacrimation in one rat on the day of dosing.
Body weight:
Slightly depressed body weight gain was observed in one female throughout the two week observation period. Body weight gains of the remaining rats appeared to be within the normal limits.
Gross pathology:
No abnormal findings.
Other findings:
None

Any other information on results incl. tables

The dermal LD50 in the rat was determined to be >10 ml/kg bw (reviewer comment: presumed equivalent to >5740 mg active
salt/kg bw).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal limit study conducted to GLP (reliability score 1) the LD50 for Briquest 301-32S (a sodium salt of ATMP) was greater than 10 ml/kg (calculated to be equivalent to >4436 mg parent acid/kg bw) in rats.
Executive summary:

In an acute dermal limit study conducted to GLP (reliability score 1) the LD50 for Briquest 301-32S (a sodium salt of ATMP) was greater than 10 ml/kg (calculated to be equivalent to >4436 mg parent acid/kg bw) in rats.