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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Nasal hemorrhage, sluggish locomotion and ruffled, unkempt coats were noted at 250 mg/kg. At dosage level of 500 mg/kg, 630 mg/kg and 800 mg/kg, the animals were lethargic with ruffled, unkempt coats. Spasmodic movements were noted. Within on hour, all animals were in a fetal position. Lacrimation, ocular and nasal hemorrhage were noted. Convulsions began approximately two hours after dosing. The animals dosed at 1000 mg/kg and 2000 mg/kg showed the same toxicity as at 800 mg/kg. All animals died within 2 -4 hours after incubation. 

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:
1976-01-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
No further information available.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
250 mg/kg
500 mg/kg
630 mg/kg
800 mg/kg
1000 mg/kg
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female were used for each dose level.
Control animals:
no
Sex:
male
Dose descriptor:
LD50
Effect level:
725 mg/kg bw
Based on:
test mat.
95% CL:
605 - 875
Sex:
female
Dose descriptor:
LD50
Effect level:
775 mg/kg bw
Based on:
test mat.
95% CL:
670 - 895

Nasal hemorrhage, sluggish locomotion and ruffled, unkempt coats were noted at 250 mg/kg. At dosage level of 500 mg/kg, 630 mg/kg and 800 mg/kg, the animals were lethargic with ruffled, unkempt coats. Spasmodic movements were noted. Within on hour, all animals were in a fetal position. Lacrimation, ocular and nasal hemorrhage were noted. Convulsions began approximately two hours after dosing. The animals dosed at 1000 mg/kg and 2000 mg/kg showed the same toxicity as at 800 mg/kg. All animals died within 2 -4 hours after incubation.

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 value of the test item is 725 mg/kg (male albino rats), therefore the test item will be classified as acute toxic; category 4; oral, H302.
Executive summary:

The study was performed 1976, before GLP- and OECD-testing guidelines were available and in force.

In this assay toxicity was recorded . LD50 value of the test item is 725 mg/kg (male albino rats), therefore the test item will be classified as

acute toxic; category 4; oral, H302 according to GHS/CLP classification criteria.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
725 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

Justification for selection of acute toxicity – oral endpoint
OECD Guideline Study and according to GLP.

Justification for classification or non-classification

The LD50 value of the test item is 725 mg/kg (male albino rats), therefore the test item will be classified as acute toxic; category 4; oral, H302.