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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
January 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 2.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

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: SLAC Laboratory Animal Co., Ltd.
- Age at study initiation: approximately 7 to 8 weeks old. It was clear that all of female animals were nulliparous and not pregnant.
- Weight at study initiation: 217 to 233 g.
- Acclimation period: animals were acclimatized to the laboratory conditions for five days prior to test, and during the time of quarantine, no infections were found in the animal colony.
- Housing: animals from each treatment group were kept in standard size cages. Cages and feeding were changed and sanitized weekly.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 50-70 %

ALLOCATION TO GROUPS
The day of treatment, all animals were weighed and required number of animals was selected by discarding those at the extremes of the weight range. In each group, individual weights of animals must not deviate from the mean group weight by more than ± 20 %.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: edible oil
Details on dermal exposure:
TEST SITE
- Area of exposure: back part of animals with areas of 4×5 cm2 were shaved.
- Type of wrap if used: the application sites were covered with one layer of gauze and two layers of plastic film. The film was fixed with adhesive tape tightly to animals.

REMOVAL OF TEST SUBSTANCE
- Washing: yes; the application sites were rinsed completely with warm water and appropriate solvent, and then dried with paper towels.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Preparation: the prescribed amounts of test substance were weighed with an automatic balance.

VEHICLE
- Preparation: the prescribed amounts of the test substance were confected with edible oil to mash.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 females and 5 males per both test item and control groups (total 20 animals)
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: every animal was observed at 0.5 hr and 4 hr after administration, and at least once daily in the following days. Clinical symptoms were recorded. Body weights at the 0th, 7th and 14th day were recorded.
- Necropsy of survivors performed: no animals were found accidentally killed, dead and moribund. Survival animals were euthanatized using CO2 after observation period. Then the gross necropsy was performed.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: dermahemia, bruise, fluffy fur, ophthalmoptosis, blood discharge, slow breathing, rapid breathing, ached back, lethargic, unusual cry, agitated, unusual posture, limply, jumping, mast tail, tremors, spasm, convulsion, unbalanced movement, retard reaction, sensitive, diarrhea, anorexia, pupil dilation, pupil reduction, salivating, tearing, dirty perineum, urine incontinence, discharge.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death was found during observation.
Clinical signs:
No clinical sign was observed during the observation time.
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to CLP Regulation (EC no. 1272/2008)
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

A single dose 2000 mg/kg bw of the test item was administered to five males and five females.

Clinical signs and mortality were observed for 14 days after dosing.

No deaths occurred and no clinical sign substance-related were observed.

Conclusion

LD50 > 2000 mg/kg bw .

The substance is not classifed for dermal acute toxicity according to the CLP regulation (EC no. 1272/2008).