Registration Dossier

Administrative data

Description of key information

The substance was tested in an acute oral toxicity study with Sprague-Dawley rats, performed according to OECD 401 test guideline but not under GLP. No deaths occurred. Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery was apparently complete by day 3.
Slightly low bodyweight gains were recorded on day 8 for two male and one female rat. Other rats achieved anticipated bodyweight gains throughout the study. At gross pathology no abnormalities were seen.
The LD50 of the substance was established to be >5000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 22, 1987 - August 05, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD 401 Guideline, but predating GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
no
Remarks:
Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, U.K.
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 103 - 128 g
- Fasting period before study: overnight prior to and approximately 4 hours after dosing
- Housing: Group housed per sex in metal cages with wire mesh floors
- Diet: A standard laboratory rodent diet (Labsure LAD 1) was provided ad libitum
- Water: water was provided ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 68
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.26 mL/kg

Doses:
5000 mg/kg bodyweight
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 and weighing: Animals were observed soon after dosing at frequent intervals for a Day. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes, all animals were killed on day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination.
- Body weight: Day 1, 8 and 15.
Statistics:
Not required.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was apparently complete by day 3.
Body weight:
Slightly low bodyweight gains were recorded on day 8 for two male and one female rat. Other rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
No abornormalities were observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with rats, performed according to OECD 401 test guidelines, an LD50 >5000 mg/kg bw was determined.
Executive summary:

The substance was tested in an acute oral toxicity study with Sprague-Dawley rats, performed according to OECD 401 test guideline, but not under GLP.

No deaths occurred. Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery was apparently complete by day 3.

Slightly low bodyweight gains were recorded on day 8 for two male and one female rat. Other rats achieved anticipated bodyweight gains throughout the study. At gross pathology no abnormalities were seen.

The LD50 of the substance was established to be >5000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The one study available is sufficiently adequate to cover this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
The one study is available is conducted according to OECD 401 guideline and is sufficiently adequate.

Justification for classification or non-classification

The substance does not have to be classified and labelled for acute oral toxicity in accordance with Regulation EC No. 1272/2008 and Directive 67/548/EEC.