Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
other: Limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers taking care to avoid damaging the skin, exposing an area equivalent to approximately 10% of the total body surface area. The test substance was applied by spreading it evenly over the prepared skin. The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal. Treatment in this manner was performed on Day 1 (day of dosing) of the study only. At the end of the 24 hours exposure period the dressing was carefully removed and the treated area of skin was washed with warm water (30 - 40°C), to remove any residual test substance. The treated area was blotted dry with absorbent paper. A record of the weight of the test substance dispensed and the amount remaining after dosing was made. The balance of these two weights was compared with the predicted usage as a check that the doses had been administered correctly.
Duration of exposure:
24 hours.
Doses:
A group of ten rats (five males and five females) was treated at 2000 mg/kg bodyweight.
No. of animals per sex per dose:
5.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths or signs of adverse effects
Clinical signs:
Very slight irritation in one animal Day 2; resolved by Day 3
Body weight:
Slight reduction or reduced gain in body weight in some animals. Significance not clear.
Gross pathology:
No histological findings

Any other information on results incl. tables

There were no deaths and no systemic response to treatment in any animal. Very slight erythema was seen in one animal on Day 2. This reaction had resolved by Day 3. A loss of bodyweight was noted in one male, and a low or no bodyweight gain was noted for three females between Days 1 and 8. A low bodyweight gain was also noted for one female between Days 8 and 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15. See attached background material for tables summarising information on dermal reactions, individual and group mean bodyweights, individual bodyweight changes, and macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the test substance to rats was found to be >2,000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 402. A group of 10 rats (5 males and 5 females) received a single topical application of the test substance, as supplied, at a dose level of 2000 mg/kg bodyweight, for a duration of 24 hours. There were no deaths and no systemic response to treatment in any animal. Very slight erythema was seen in one animal on Day 2. This reaction had resolved by Day 3. A loss of bodyweight was noted in one male, and a low or no bodyweight gain was noted for three females between Days 1 and 8. A low bodyweight gain was also noted for one female between Days 8 and 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15. The acute dermal LD50 of the test substance to rats was found to be >2000 mg/kg bw.