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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
11 Jan - 12 Mar 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01

Test animals

Species:
rat
Strain:
other: Rat Ico: OFA.SD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA-CREDO, L'Arbreles, France
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 163-172 g (males) and 138-149 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed in groups of 5 per sex in polycarbonate cages type MI (365 x 225 x 180 mm) with dust-free sawdust bedding from spruce tree wood.
- Diet: pelleted complete diet, diet reference A04 C10 (Usine d'Alimentation Rationnelle, Epinay/Orge, France), ad libitum
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% (w/w)
- Lot/batch no.: A28557/1
- Purity: pure
Test substance preparation was administered within 4 hours of preparation.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed for clinical signs 15 min, 1 h, 2 h and 4 h after administration of the test subsatnce and daily during the 14-day observation period. Individual body weights were determined on Day -1, immediately before administration on Day 0, and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
In a preliminary study, 2.5, 5 and 10% of the test substance in vehicle (corresponding to 500, 1000 and 2000 mg/kg bw) were administered to 2 males and 2 females per test group. No mortality was observed at any of the concentrations tested. Thus, a dose of 2000 mg/kg bw (10% test concentration) was chosen for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality way observed during the study period.
Clinical signs:
There were no abnormal clinical signs in any of the treated animals during the observation period.
Body weight:
There were no treatment-related effects.
Gross pathology:
There were no macroscopic findings at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified