Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to EEC Directive 92/96, B.1. Study conducted under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
Method: other: EEC Directive 92/69. B.1.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil DAB 10
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights determined shortly before application, weekly thereafter and at the end of the study. Recording of clinical signs several times on day of administration, at least once each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights,

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality observed.
Clinical signs:
No sympthoms were recorded for female animals.

Male animals suffered from impaired general state, poor general state, dyspnoea, apathy, staggering, twitching, piloerection, smeared fur, red adhesive snout and compulsary gnawing. All sympthomes disappeared within the firt 3 days after administration.
Body weight:
Mean body weight of male animals [g] before/7/13 days after application: 171/224/263
Mean body weight of female animals [g] before/7/13 days after application: 180/207/219
Gross pathology:
No pathologic findings noted in any of the test animals.

Applicant's summary and conclusion

Conclusions:
Based on the results of this study, the test substance Asta-C15-acetal (C15-ACL) does not need to be classified according to Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC.