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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: LD50 = 5000 mg/kg bw for rat. No valid data for

exposure via dermal or inhalation route.

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: cited in BG 249 (Hoechst study)
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
up to 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Mortality:
dosage of 3150 to 4000 mg/kg bw no death occured. with 5000 mg/kg bw 2 males and 3 females died. the male animals died within the first day, the female animals died between day 9 and day 14.
Clinical signs:
other: ruffled coat, diminished activity, increased startle response, constricted eye lids, diarrhoe, gasping at the highest dose
Gross pathology:
intestine filled with white-yellowish pulp, accumulation of blood in the lung, thorax filled with red liquid, liver partly brighten

Male animals died within the first day post application, the female animals died between day 9 and day 14. In these animals the intestine with white-yellow pulp, lungs were hemorrhagicand thorax filled with red liquid. Until the second day post application clinical signs were seen in all dose groups, specially crouch, elevated startle response, ruff fur, constricted eye palpebral fissure and diarrhoea. Three days after application of the test substance no clinical signs were evident. Animals killed after post observation period (14 to 21 days) were free of maroscopic visible changes

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

method: oral toxicty study according OECD 401.

result: LD50 is about 5000 mg/kg bw

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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

In an acute oral guideline study in male and female rats a LD50 of ca. 5000 mg/kg bw was found.

Justification for classification or non-classification

Because the acute oral LD50 is about 5000 mg/kg bw a classification is not justified for the oral route.

Based on read across with phenyl isozyanate (Pauhuln 2015) Acute Tox. 1; H330 (fetal if inhaled) is appropriate.