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Diss Factsheets

Administrative data

Description of key information

Oral (OECD 401), rat: LD50: > 2000 mg/kg bw (limit test)

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24 Feb 1987
Deviations:
yes
Remarks:
No data on analytical purity of test substance given.
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH AND SOCIAL SECURITY OF THE GOVERNMENT OF THE UNITED KINGDOM, UK
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD(SD)BR
Remarks:
(VAF plus)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: approx. 100 g
- Fasting period before study: overnight
- Housing: in groups of 5, by sex, in grid bottomed cages suspended over cardboard lined excreta trays
- Diet: pelleted rat diet (SQC Rat and Mouse Maintenance Diet No.1 Expanded,Special Diets Services, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 (The temperature dropped 1°C below the protocol specified range on one occasion only and this deviation is considered not to have affected the outcome of the study.)
- Humidity (%): 47 - 65
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
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 and weighing: All animals were examined approximately 30 min, 1, 2 and 4 h after dosing and daily thereafter for 14 consecutive days. All animals were weight immediately before dosing and on Day 8 and 15 thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2/5 females had to be killed in extremis 5 h 20 min after dosing
Clinical signs:
other: 2/5 females were found hypoactive and ataxic 4 h after dosing. Breathing was slow in both females and one female was laterally recumbent. 1.20 h later both animals were prostrate with eyes half closed, exhibiting slight piloerection, red/black bilateral p
Gross pathology:
There were no treatment related necropsy findings.

Table 1. Results of acute oral toxicity in rats.

Dose level

(mg/kg bw)

Mortalities

Clinical signs

male

2000

0/5

5/5

female

2000

2/5 (killed in extremis)

5/5
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was found.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch Score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 Feb 1987
Deviations:
yes
Remarks:
No data on purity of test substance given.
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH AND SOCIAL SECURITY OF THE GOVERNMENT OF THE UNITED KINGDOM, UK
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD(SD)BR
Remarks:
(VAF plus)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: approx. 200 g
- Housing: individually in grid bottomed cages suspended over cardboard lined excreta trays
- Diet: pelleted rodent diet (SQC Rat and Mouse Maintenance Diet No.1 Expanded, Special Diets Services, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 47 - 65
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: The treated site was covered with a pad of surgical gauze 4 plies thick overlaid with a strip of aluminium foil and was held in place by an elastic adhesive bandage (Elastoplast).

REMOVAL OF TEST SUBSTANCE
- Washing: Treated skin was washed by gentle swabbing with cotton wool soaked in warm water.
- Time after start of exposure: 24 h

Duration of exposure:
24 h
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 and weighing: All animals were examined for signs of toxicity approximately 30 min, 1, 2 and 4 h after
dosing and daily thereafter for 14 days. All animals were weighed on Day of dosing and on Day 8 and 15 after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalitiy was noted until the end of the observation period.
Clinical signs:
other: Brown perinasal staining was noted in all animals from 1 to 2 hours after dosing, but most animals had recovered by Day 4. Brown fur staining on the forepaws and in the head and neck region 4 h after dosing, probably caused by cleaning themselves.
Gross pathology:
All necropsy findings (enlarged submandibular lymph nodes) are considered to be consistent with the background macroscopic pathology of this rat strain.
Other findings:
- Other observations: About 22 h after dosing, one female was found to have chewed through the bandage and removed the dressing.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute dermal toxicity study a LD50 value > 2000 mg/kg bw in male and female rats was found.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Oral

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1992). Groups of 5 male and 5 female rats were given a total dose of 2000 mg/kg bw of the test substance via gavage. 2/5 females were killed in extremis ca. 5 h after dosing because they were found in a moribund state. Slight signs of toxicity were observed in all rats treated with the test substance shortly after dosing, completely recovered by Day 2. Thus, an oral LD50 > 2000 mg/kg bw for male and female rats was determined.

Dermal

The acute dermal toxicity of the test substance was assessed in a limit test performed in 5 male and 5 female rats according to OECD Guideline 402 and in compliance with GLP (1991). A single dose of 2000 mg/kg bw of the test substance was applied to the clipped skin of the rats under occlusive conditions for 24 hours. No mortality occured, thus a dermal LD50 > 2000 mg/kg bw for male and female rats was determined.

Justification for classification or non-classification

The available data on acute oral and dermal toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.