Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

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:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA CREDO breeding centre (69210 Saint-Germain sur l'Arbresle)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 160 - 200 g (males); 140 - 180 g (females)
- Fasting period before study: yes. Animals were fasted for 16 - 20 hours prior to dosing.
- Housing: groups of 2 or 5/cage
- Diet: UAR maintenance feed A04 ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 changes per hour

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Animals were administered unchanged test material, orally, in the morning (day 0). Control animals received 5.56 mL/kg water and treated animals received 5.00 mL/kg test material.
Doses:
1000, 2500, 5000 mg/kg (preliminary study)
0, 5000 mg/kg (definitive study)
No. of animals per sex per dose:
2 males and 2 females per dose (preliminary study)
5 males and 5 females per dose (definitive study)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: behaviour and mortality were observed immediately following treatment with the test material and again after 1, 2 and 4 hours. Animals were observed daily thereafter. Body weights were recorded on study days -1, 0, 7 and 14 (and at time of death if the animal survived more than 24 hours).
- Necropsy of survivors performed: yes. An autopsy of animals found dead or sacrificed at the end of the observation period was performed.
Statistics:
Not reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No effects were observed at this dose level.
Mortality:
None of the animals died during the study.
Clinical signs:
No behavioural anomaly was detected at the end of the treatment and during the 14 day observation period.
Body weight:
The bodyweights of the treated animals was in general comparable to those of the controls.
Gross pathology:
No detectable microscopic anomaly was detected, in any of the animals, at necropsy.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the acute oral LD50 of the test material was determined to be in excess of 5000 mg/kg.
Executive summary:

The acute oral toxicity of the test material was determined in accordance with standardised guidelines OECD 401 and EU Method B.1. In a preliminary study, groups of two male and two female rats were orally dosed 1000, 2500 and 5000 mg/kg test material, respectively. Animals were observed for a period of 14 days following treatment for mortality. Since none of the animals died, the definitive study was conducted with a single group of 5 males and 5 females treated with 50000 mg/kg test material and another group of 5 males and 5 females treated with water alone. During the study none of the animals died, no clinical signs were reported and the bodyweights of the treated animals were comparable to those of the controls. No detectable microscopic anomaly was detected, in any of the animals, at necropsy. Therefore, under the conditions of the study, the acute oral LD50 of the test material was determined to be in excess of 5000 mg/kg.