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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral 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

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All animals were fasted for 18 hours prior to dosing. Dosing was by gavage using a ballpoint needle fitted to a syringe. After dosing the animals were given food and water ad libitum.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The test material was administered undiluted. Five rats of each sex were given doses of 5000 mg/kg.
Rats 9-11 weeks old at the time the test commenced. All animals were fasted overnight. Dosing was by gavage using a ballpoint needle fitted to a syringe. After dosing the animals were given food and water ad libitum and 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:
> 5 000 mg/kg bw
Remarks on result:
other: No deaths at the maximum dose
Mortality:
none
Clinical signs:
Most had piloerection and diarrhea on day 1. All rats had an unkempt appearance on subsequent days. Females recovered by day 4, but males did not recover until day 6.
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 14 (g)

Summary of signs and times of onset and recovery

643 F

 

644 F

 

645 F

 

646 F

 

647 F

 

643 M

 

644 M

 

645 M

 

646 M

 

647 M

 

5000

 

5000

 

5000

 

5000

 

5000

 

5000

 

5000

 

5000

 

5000

 

5000

 

140

 

135

 

167

 

144

 

135

 

191

 

211

 

206

 

181

 

199

 

161

 

152

 

158

 

163

 

155

 

204

 

239

 

237

 

205

 

225

 

172

 

161

 

167

 

171

 

155

 

229

 

256

 

258

 

226

 

246

 

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6.

Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test material in rats, administered undiluted, was greater than 5000 mg/kg.
Executive summary:

None of the rats died from which it was concluded that the acute oral LD50 of EPIKOTE 862, administered undiluted, was greater than 5000 mg/kg.

All rats were affected by the test material. Most had piloerection and diarrhea on day 1. All rats had an unkempt appearance on subsequent days. Females recovered by day 4, but males did not recover until day 6.All rats had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period.