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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 toxicity via oral and dermal route were determined to be > 5000 mg/kg b.w.

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: Comparable to guideline study with acceptable restrictions.
Principles of method if other than guideline:
Method: other: Federal Register, 1978, 43, 37355-6, a standard acute method.
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:
water
Doses:
5000, 2500, 1250, 650
No. of animals per sex per dose:
6
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw

MORTALITY:  
- Time of death: Not documented
- Number of deaths at each dose: 1 male and 1 female in top does (5000 mg/kg).

CLINICAL SIGNS:  
Diarrhea and slight tremors were observed in the rat that subsequently died. All surviving rats appeared healthy and gained weight during the 2-week observation period.  

NECROPSY FINDINGS: none
POTENTIAL TARGET ORGANS: not identified
SEX-SPECIFIC DIFFERENCES: not reported.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 of >5000 mg/kg: no EU classification for acute oral toxicity.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
LD50 >5000 mg/kg

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:
other: 2d: Test procedure in accordance with national standard methods with acceptable restrictions.
Qualifier:
according to guideline
Guideline:
other: Federal Register, 1978, 43, 37355-6
Principles of method if other than guideline:
Single exposure for 24 h to single dose of 5000 mg/kg undiluted. Observation period 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Sex:
male/female
Vehicle:
other: undiluted
Doses:
5000 mg/kg single dose
No. of animals per sex per dose:
2
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw

All rabbits survived and no signs of systemic toxicity were  observed following application of the test material. No redness swelling of necrosis was observed on the treatment site when the sleeves were removed. Pre treatment weight was  regained 1 week post-treatment. Upon gross pathological examination, mild petechial hemorrhages were observed in the  subcutaneous fat and fascia at applications sites.  Underlying muscle was not involved. The skin was viable and  intact. No other lesions attributable to treatment were  observed.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 of >5000 mg/kg: no EU classification for acute oral toxicity.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
LD50 >5000 mg/kg bw

Additional information

Justification for classification or non-classification

LD50 values for oral and dermal route > 5000 mg/kg/bw do not warrant classification (GHS).