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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral toxicity: The LD50 value was determined to be 1390 mg/kg (male/female).
Acute dermal toxicity: The LD50 value was determined to be 2800 mg/kg.

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:
other: No GLP and guideline compliant study.
Principles of method if other than guideline:
No data about the method available
GLP compliance:
not specified
Test type:
acute toxic class method
Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: Young adult
- Weight at study initiation: No data
- Fasting period before study: 18 hr


Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
No data
No. of animals per sex per dose:
5 animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight,organ weights
Statistics:
LD50 was computed by the method of Litchfield & Wilcoxon.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 390 mg/kg bw
Based on:
test mat.
95% CL:
> 1 140 - < 1 700
Mortality:
Mortality occured after 4hr - 10 days (most deaths within 2 days).
Clinical signs:
other: Depression within 1 hr after treatment, porphyrin-like deposit around eyes and nose.
Gross pathology:
Gross pathology showed discoloured live, irritated gastro- intestinal tract, stomach haemorrhage, yellowish material attached to the intestines.
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is harmful if swallowed. The LD50 value was determined to be 1390 mg/kg (male/female).
Executive summary:

The acute oral toxicity test was conducted with 10 young adult Osborne-Mendel rats evenly divided by sex. The animals were fasted approximately 18 hours prior to treatment. All doses were given by intubation. The animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks. Following observations were made: Depression within 1 hour after treatment, scrawny appearance, porphyrin-like deposit around eyes and nose. Gross pathology examinations showed discoloured liver, irritated gastro- intestinal tract, stomach haemorrhage, yellowish material attached to the intestines.

The LD50 value was determined to be1390 mg/kg (male/female).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 390 mg/kg bw
Quality of whole database:
No GLP and guideline compliant study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 800 mg/kg bw
Quality of whole database:
No GLP and guideline compliant study.

Additional information

Acute oral toxicity:

The acute oral toxicity test was conducted with 10 young adult Osborne-Mendel rats evenly divided by sex. The animals were fasted approximately 18 hr prior to treatment. All doses were given by intubation. The animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks. The observations were depression within 1 hr after treatment, scrawny appearance, porphyrin-like deposit around eyes and nose. Gross pathology showed discoloured live, irritated gastro- intestinal tract, stomach haemorrhage, yellowish material attached to the intestines.

The LD50 value was determined to be1390 mg/kg (male/female).

Acute dermal toxicity:

In Denine, 1973 (Report to RIFM, 12 April) the acute dermal LD50 in rabbits of 2800 mg/kg was reported.


Justification for selection of acute toxicity – oral endpoint
Available study

Justification for selection of acute toxicity – dermal endpoint
Available data.

Justification for classification or non-classification

Based on the result of the acute oral toxicity test the test substance has to be classified as Cat.4 H302: Harmful if swallowed according to Regulation (EC) No 1272/2008 (CLP) and as Acute Tox.4, respectively Xn;R22: Harmful if swallowed according to the criteria of Directive 67/548/EEC (DSD).

Based on the result of the acute dermal toxicity test to the test substance, classification is not warranted according to the criteria of Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).