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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:
weight of evidence
Study period:
From March 31, 1981 to April 14, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was administered orally by gavage in graduated doses to several groups of experimental animals, one dose being used per group. Subsequently observations of effects and deaths are made. Animals which die during the test are necropsied, and at the conclusion of the test the surviving animals are sacrificed and necropsied.
GLP compliance:
yes
Test type:
other: Hagan et al 1959 Method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5 gm/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No moratality was observed.
Body weight:
No significant changes in bodyweight were observed in any animal.
Gross pathology:
No gross changes were observed in all animals.

Any other information on results incl. tables

Results

Animal No and Sex

Bodyweight (gm)

Hours

Days

Bodyweight (gm)

1

3

6

24

2

3

4

5

6

7

8

9

10

11

12

13

14

 

1M

244

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

372

2M

240

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

364

3M

244

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

378

4M

264

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

418

5M

234

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

368

6F

226

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

276

7F

244

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

300

8F

240

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

308

9F

230

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

284

10F

248

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

296

N = Normal

D= Depression

SD = Slight Depression

XD = Severe Depression

Applicant's summary and conclusion

Interpretation of results:
other: not classified based on EU CLP criteria
Conclusions:
Under the study conditions, the LD50 of the test substance was determined to be >5000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute toxicity potential of the test substance, 'Cocodimonium hydroxypropyl hydrolysed keratin' (active content not specified), according to a method described by Hagan et al 1959, in compliance with GLP. Ten albino rats (5 animals each sex), weighing 200 to 300 g, each received a single oral dose of the test substance at a dose level of 5000 mg/kg bw. Animals were observed for pharmacological activity and drug toxicity at 1, 3, 6 and 24 h after treatment and daily thereafter for a total of 14 d. Non-survivors and animals surviving the 14 d observation period were subjected to gross necropsy, with all findings noted. No significant changes in bodyweight or gross were observed in any animal. Under the study conditions, the LD50 of the test substance was determined to be >5000 mg/kg bw (CPT 1981).