Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 19, 1994 to November 30, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (OECD 401) with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): 7-ACA
- Physical state: white powder
- Analytical purity: 95%-102% (HPLC)
- Impurities: 7-ACA 4.7%
- Batch No.: 3701586
- Expiration date of the batch: stable under conditions of storage
- Storage condition of test material: in a refrigerator in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals:
Supplier: Forschungsinstitut für Versuchstierzucht, A-2325 Himberg
Age: approximately 8 weeks at time of administration
Environment:
Room temperature: average of 22 °C,
Humidity: average of 55 %,
Air exchange: 12 per hour,
Light artificial light from 6 a.m. to 6 p.m.,
Cages: Single caging in Makrolon cages type III,
Bedding material: Aspen wood chips, type "4 HV",
Feed: Altromin 1314 ff, gamma irradiated with 10 kGy 60Co, ad libitum,
Water: tap water, offered in Makrolon bottles with stainless steel canules, ad libitum,
Acclimatization: 6 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Carboxymethylcellulose, sodium salt
Details on oral exposure:
Peroral administration was performed within maximum 30 minutes after preparation of the test substance suspension once in the morning by stomach intubation using a metal gavage. The test substance suspension was stirred during the time of administration.
Doses:
2000 mg/kg body weight (20 ml/kg)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Observations in life: Behaviour, reactions and physical signs of the animals were observed 0-0.5, >0.5-1, >1-2, >2-4 and >4-6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 2 weeks.

Body weight and body weight gain: Body weight was determined before administration, 7 days p.a. and 14 days p.a.
Body weight gain was calculated for each week of the study, i.e. 0-7 d p.a. and 7-14 d p.a.

Necropsy: All animals were sacrified by CO2 14 days p.a. and examined macroscopically in an attempt to detect possible residual lesions.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals (5 males and 5 females) survived until the scheduled termination of 14 days p.a.
Clinical signs:
Males: 3/5 animals were normal during the whole obser vation period. In the affected males chromodacryorrhoea, an unspecific sign of general malaise, was noted on day of administration of the test substance for about 2 hours.
Females: All animals, i.e. 5 females, were normal during the whole observation period.
Body weight:
Males and females: At the scheduled examination terms, body weight and body weight gain were inconspicuous in all animals.
Gross pathology:
Males and females: All animals were normal at terminal necropsy.
Other findings:
Sex differences: Signs in life and post mortem findings revealed no differences between the sexes in the response to the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 is above 2000 mg/kg bw.
Executive summary:

An acute oral toxicity study with rats was performed. The LD50 is above 2000 mg/kg bw.