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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:
From January 05, 2017 to April 25, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI
Sex:
male/female
Details on test animals and environmental conditions:
- Source: Charles River Laboratories, Research Models and Services
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 223-252g
- Housing: Individual caging
- Acclimation period: 5 Days
- Temperature (°C): 20.1 – 24.9 °C
- Humidity (%):30 – 48%
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Type of coverage:
semiocclusive
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
There were no systemic clinical signs noted in any animal throughout the study. But reddish discoloration by the test item was observed on the treated area on Day 1 and 2 after the application.
Body weight:
One female rat (animal no. 5897) was observed that slight body weight loss between Day 7-14.
Gross pathology:
There was no evidence of any gross macroscopic changes.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
According to OECD 402 test method, the LD50 of CJ302 was greater than 2000 mg/kg body weight. Therefore, CJ302 was Category 5 or Unclassified based on GHS criteria.
Executive summary:

This test using the procedures outlined in the CiToxLAB Study Plan for16/375-002Pand OECD 402 (OECD, 1987). A limit test was carried out at 2000 mg/kg body weight in both sexes (5 rats/sex) of Crl:WI Wistar rats. CJ302 did not cause mortality and no evidence of any gross macroscopic changes in necropsy. There were no systemic clinical signs noted in any animal throughout the study. There were no treatment related effects on body weight or body weight gain during the observation period. Therefore, LD50 of CJ 302 was greater than 2,000 mg/kg B.W..