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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral LD50 is 4100 mg/kg bw

Dermal LD50 is >5000 mg/kg bw

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Description: Clear liquid
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300g
- Fasting period before study: 18 hours
- Diet: ad libitum
- Water: ad libitum
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
1220, 2470, 5000, 10140 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: mortality, toxicity, pharmacological effects, gross pathology
- Frequency of observations: daily
Statistics:
LD50 and 95% Confidence Limits were calculated by the method of Litchfield and Wilcoxon (J. Phar. & Exp. Therap. 96:99, 1949)
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
4 100 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 800 - <= 5 900
Mortality:
1220 mg/kg bw: No mortality
2470 mg/kg bw: 1/10 (One animal died on day 1)
5000 mg/kg bw: 7/10 (Four animals died on day 1; two animals died on day 2, and one animal died on day 7)
10140 mg/kg bw: 10/10 (Six animals died on day 1; three animals died on day 2, and one animal died on day 7)
Clinical signs:
other: 1220 mg/kg bw: diarrhea, lethargy, ptosis 2470 mg/kg bw: lethargy, diarrhea, flaccid tone 5000 mg/kg bw: diarrhea, lethargy, flaccid tone, ataxia, ptosis, piloerection, coma. 1/4 survivors on day 4 had hair loss on head and neck 10140 mg/kg bw: diarrhea,
Gross pathology:
1220 mg/kg bw: No abnormalities observed
2470 mg/kg bw: The animal who died had red exudate of the nose/mouth region, yellow exudate of the anogenital region, red areas in the intestines, dark liver, dark lungs, and dark kidney. Of the nine animals who were sacrificed after 14 days, in 6 animals, no abnormalities were observed and in 3 animals dark areas in the lung were observed.
5000 mg/kg bw: In the seven animals who died the following observations were made: Red exudate of the nose/mouth region (2/7), Red exudate of the nose/mouth region (4/7), Brown exudate of the anogenital region (7/7), Red areas in the intestines (6/7), Bloated intestines (5/7), Stomach, liver and intestines covered by white opaque substance (1/7), Mottled liver (2/7), Dark lungs (3/7), Dark areas in the lung (4/7), Dark kidney (3/7), and Mottled spleen (1/7). In the animals who were sacrificed after 14 days no abnormalities were observed.
10140 mg/kg bw: The following observation were made: Red exudate of the nose/mouth region (10/10), Yellow exudate of the anogenital region (10/10), Red areas in the intestines (2/10), Bloated intestines (1/10), Bloated stomach (1/10), Dark liver (4/10), Mottled liver (6/10), Dark areas in the lung (10/10), Dark kidney (10/10), Dark spleen (3/10), Small spleen (1/10)
Interpretation of results:
Category 5 based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
4 100 mg/kg bw
Quality of whole database:
One Klimisch 2 study available. Performed similar to guideline.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Description: Clear liquid
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9 - 2.6 kg
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Type of wrap if used: The area was covered with gauze and the trunk wrapped with impervious material
- In half, abrasions were made longitudinally every 2-3 cm over the exposed area. The abrasions were sufficiently deep to penetrate the stratum corneum but not deep enough to produce bleeding.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: mortality, clinical signs, body weight, skin reactions (Draize), gross pathology
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
other: Diarrhea in one animal was observed on day 1.
Gross pathology:
Brown anogenital exudate was observed in 3 animals. Bloated intestines was observed in 3 animals. Dark liver was observed in all animals. Mottled kidneys were observed in 9 animals.
Other findings:
Skin reactions on day 1
- Erythema: All animals had a score of 2
- Eschar: 7 animals had a score of 2 and 3 had a score of 3
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
One Klimisch 2 study available. Performed similar to guideline.

Additional information

Acute oral:

In an acute oral toxicity study performed similar to OECD 401 (except body weight determination), the test substance was administered via oral gavage to ten male Wistar rats per dose group. The concentrations administered were 1220, 2470, 5000, and 10140 mg/kg bw and the animals were observed for 14 days. The mortality observed was 0, 10, 70, and 100% for the 1220, 2470, 5000, and 10140 mg/kg bw dose groups, respectively. Adverse effects observed included diarrhea, lethargy, ptosis, flaccid tone, ataxia, and piloerection. The LD50 was determined to be 4100 mg/kg bw (CI: 2800 - 5900 mg/kg bw).

Acute dermal:

In an acute dermal toxicity study performed similar to OECD 402, the test substance was administered dermally under occlusive conditions for 24 hours to ten New Zealand White rabbits. The concentration applied was 5000 mg/kg bw and the animals were observed for 14 days. In half, abrasions were made longitudinally every 2-3 cm over the exposed area. The abrasions were sufficiently deep to penetrate the stratum corneum but not deep enough to produce bleeding. No mortality was observed. The only adverse effect observed was diarrhea in one animal on day 1. Brown anogenital exudate and bloated intestines were observed in 3 animals. Dark liver was observed in all animals and mottled kidneys were observed in 9 animals. Skin reactions were observed in all animals on day 1 (Erythema: Draize score of 2 in all animals; Eschar: Draize score of 2 in 7 animals and a score of 3 in 3 animals. The LD50 was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

The test substance does not have to be classified for acute oral or dermal toxicity according to Regulation (EC) No 1272/2008.