Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 (male/female) = > 2000 mg/kg bw (OECD 401/GLP).

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP compliance
Qualifier:
according to guideline
Guideline:
other: OECD 401 (1987)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: rat, TIf:RAlf (SPF)
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1 %polysorbate 80.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Numberof animals: 5; Numberof deaths: 0
Female: 2000 mg/kg bw; Numberof animals: 5; Numberof deaths: 0
Clinical signs:
Signsof toxicity related to dose levels:
Unspecific symptoms of intoxication: piloerection, hunched
posture. exophthalmus and dyspnoea.
Gross pathology:
Effectson organs: no effects
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
information from migrated NONS file as per inquiry # [06-0000014493-71-0000], permission to refer granted by ECHA

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

Acute oral toxicity

There are two acute oral toxicity studies in the rat available. One study did not have sufficient documentation available for assessment in the inquiry file (RL4) and was disregarded.

In an acute oral toxicity test (OECD 401/GLP), 1 group of male and female TIf:RAlf (SPF) rats (5/group) were administered the substance in distilled water containing 0.5% carboxymethylcellulose and 0.1 % polysorbate 80 by oral gavage at 2000 mg/kg bw. Clinical signs of toxicity were piloerection, hunched posture, exophthalmus and dyspnoea; all of the animals recovered within 5-6 days. There were no deaths.No macroscopic changes in organs were diagnosed during the gross pathological examination. The LD50 (male/female) was > 2000 mg/ kg bw.

Justification for classification or non-classification

Based on the available information in the dossier, the substance is is not classified for acute oral toxicity, when the criteria outlined in Annex I of 1272/2008/EC are applied.