Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In accordance with internationally valid GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
EPIKOTE 862

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
ANIMALS
Source: Charles River UK
Age: 9-11 weeks
Housing: singly in stainless steel cages
Food: ad libitum, PRD, Labsure Animal Foods, and water
Temperature: 19-25 degrees C
Lighting: 12 hour light dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
All animals had 60% of their dorsal hair removed the day prior to dosing. A 2000 mg/kg dosing was applied by syringe and covered with gauze and held in place with elastic tape. Rats were individually housed and given water ad libitum for 24 hours before the removal of the dressing and washing of the skin.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
All animals had 60% of their dorsal hair removed the day prior to dosing. A 2000 mg/kg dosing was applied by syringe and covered with gauze and held in place with elastic tape. Rats were individually housed and given water ad libitum for 24 hours before the removal of the dressing and washing of the skin. After dosing the animals were observed for clinical signs three times a day for the first three days and daily for the remainder of the 14 day observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortalities were observed at the maximum dose
Mortality:
none
Clinical signs:
none
Body weight:
All rats had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period.

Any other information on results incl. tables

Animal number and sex

Dose (mg/kg)

Body wt at day 1 (g)

Body wt at day 7 (g)

Body wt at day 7 (g)

Summary of signs and times of onset and recovery

648 F

 

649 F

 

650 F

 

651 F

 

652 F

 

648 M

 

649 M

 

650 M

 

651 M

 

652 M

 

2000

 

2000

 

2000

 

2000

 

2000

 

2000

 

2000

 

2000

 

2000

 

2000

 

150

 

151

 

155

 

154

 

166

 

244

 

193

 

202

 

201

 

199

 

150

 

150

 

158

 

160

 

167

 

249

 

191

 

199

 

199

 

199

 

167

 

159

 

169

 

168

 

177

 

269

 

212

 

215

 

218

 

224

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

No signs seen.

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The acute dermal LD50 of the test material in rats, administered undiluted, was greater than 2000 mg/kg.
Executive summary:

None of the rats died from which it was concluded that the acute dermal LD50 of EPIKOTE 862, administered undiluted, was greater than 2000 mg/kg.

No clinical signs were observed during the study. All rats had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period.