Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

LD 50 oral, rat, male: 3179 mg/kg,
LD 50 oral, rat, female: 2344 mg/kg (Bomhard / Bayer Ag, 1987).
There is no reliable inhalation study available.
LD 50 dermal, rat, female: >2000 mg/kg bw (Bomhard / Bayer AG, 1992) .

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 OECD guideline defined.
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Cited as Directive 84/449/EEC, B.1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: Polyethyleneglycol 400
Doses:
1000, 2500, 2650 (only female rats), 3000, 3550, 5000 mg/kg bw.
No. of animals per sex per dose:
1000 mg/kg= 5 animals/sex,
2500 mg/kg= 5 animals/sex,
2650 mg/kg= 5 female rats,
3000 mg/kg bw= 10 male, 15 female animals,
3550 mg/kg bw= 5 animals/sex,
5000 mg/kg bw=5 animals/sex.
Control animals:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3 179 mg/kg bw
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
2 344 mg/kg bw
Interpretation of results:
GHS criteria not met
Conclusions:
The LD 50 for male rats was 3179 mg/kg and the LD 50 for female rats was 2344 mg/kg bw.
Executive summary:

In an acute oral toxicity study in male and female Wistar rats, the animals received the test substance via gavage. Following doses were tested: 1000, 2500, 2650 (only female rats), 3000, 3550, 5000 mg/kg bw. The LD 50 for male rats was 3179 mg/kg and the LD 50 for female rats was 2344 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 344 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 adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

In an acute oral toxicity study in male and female Wistar rats, the animals received the test substance via gavage. Following doses were tested: 1000, 2500, 2650 (only female rats), 3000, 3550, 5000 mg/kg bw. The LD 50 for male rats was 3179 mg/kg and the LD 50 for female rats was 2344 mg/kg bw (Bomhard / Bayer AG, 1987).

There is no reliable inhalation study available.

In an acute dermal toxicity study in male and female Wistar rats the animals were treated with the test substance for 24 h on the shaved back and flank. The dose tested was 2000 mg/kg bw. After 24 h the occlusive coverage was removed and the leftovers of test substance were washed with lukewarm water. Up to 30 minutes after application the female and male animals made sounds. After one hour all animals were symptom-free. No local skin changes were observed. During the 14 day observation-period no animal died. The LD 50 therefore was >2000 mg/kg bw (Bomhard / Bayer AG, 1992) .

Justification for classification or non-classification

The LD 50 oral for male rats was 3179 mg/kg and the LD 50 oral for female rats was 2344 mg/kg bw (Bomhard / Bayer AG, 1987). There is no reliable inhalation study available. The LD 50 dermal was >2000 mg/kg bw (Bomhard / Bayer AG, 1992) .

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification for acute toxicity is not justified.