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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The oral LD50 of male rats was > 27.4 and < 31.6 mL/kg bw. Therefore the mean oral LD50 of male rats was 30.1 mL/kg bw or 26800 mg/kg bw (density = 0.89g/cm3).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1974
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Cited from ECHA disseminated dossier Query date: 2015-07-22 For justification of read across please refer to IUCLID section 13.
Qualifier:
no guideline available
Principles of method if other than guideline:
Four groups each of 10 male rats and one group of 20 male rats were treated with the undiluted substance. The application volume was 17.8 mL/kg, 23.7 mL/kg, 27.4 mL/kg and 31.6 mL/kg, respectively. One control group with 10 male rats was treated with demineralized water at 31.6 mL/kg.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Control group: 31.6 mL/ kg demineralized water
Test group 1: 17.8 mL/kg
Test group 2: 23.7 mL/kg
Test group 3: 27.4 mL/kg
Test group 4: 31.6 mL/kg
No. of animals per sex per dose:
Control group: 10 males
Test group 1: 10 males
Test group 2: 10 males
Test group 3: 10 males
Test group 4: 20 males
Control animals:
yes
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 30.1 mL/kg bw
Remarks on result:
other: equivalent to 26800 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
26 800 mg/kg bw

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

Four groups each of 10 male rats and one group of 20 male rats were treated with the undiluted substance. The single-application volume was 17.8 mL/kg, 23.7 mL/kg, 27.4 mL/kg and 31.6 mL/kg, respectively. One control group with 10 male rats was treated with demineralized water at 31.6 mL/kg.

Mortality and clinical signs were observed during 14 days after treatment.

No deaths occurred in the control group and test groups treated with 17.8 mL/kg, 23.7 mL/kg and 27.4 mL/kg.

16 out of 20 rats died in the highest treated group (31.6 mL/kg) during the course of the study.

Systemic toxicity was observed in all test item treated groups. All clinical signs disapeared in the lowest treated group (17.8 mL/kg) after day 4 where where as the animals treated with 23.7 mL/kg, 27.4 mL/kg and the surviving animals treated with 31.6 mL/kg still showed clinical signs at the end of the observation period.

Loss of body weight was noted in the 31.6 mL/kg treated group during the first week of observation but the surviving animals did not recover completly at the end of the observation period compared with the control animals. Body weight increased in the other treated groups was comparable to the control group.

For the 31.6 mL/kg treated animals, red discoloration of the stomach with hemmorhage was noted at the unscheduled necropsy in 12 out of 16 animals. Blood in the stomach was observed in 5 animals. Red discoloration of the small intestine with hemmorhage was observed in 10 animals and blood in the small intestine was seen in 12 animals.

 

The oral LD50 of male rats was > 27.4 and < 31.6 mL/kg bw. Therefore the mean oral LD50 of male rats was 30.1 mL/kg bw or 26800 mg/kg bw (density = 0.89g/cm3).

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC.

                               

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.