A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)

Endpoint summary

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 Guideline No. 401 (equivalent to Annex V), limit test.

GLP compliance:

yes

Limit test:

yes

Species:

rat

Vehicle:

other: Destilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels:
No deaths. Dyspnoea and ruffled fur (both slight moderate) were seen from 1 hour post dose to days 8-9.

Other signs resolved by day 5and included exophtalmus and curved body posture (both slight).

Slight tonic-clonic convulsions were noted on day 1.

Gross pathology:

Effects on organs:
No gross lesions were found at necropsy.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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 403 (Limit test). Fully conforms with Annex V, B2 (Limit test).

GLP compliance:

yes

Limit test:

yes

Species:

rat

Vehicle:

other: Aerosol of 30% (w/w) test substance in absolute ethanol.

Details on inhalation exposure:

Nose only

Dose descriptor:

LC50

Effect level:

> 5.8 mg/L air

Clinical signs:

other: Signs of toxicity related to dose levels: No deaths. on exposure day, ruffled fur, dyspnea and hunched posture in all animals, and in test animals only there was reduced spontaneous activity. Control animals recovered within two days and animals exposed t

Gross pathology:

Effectson organs:
None (Particular attention was given to the respiratory tract).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5.8 mg/m³

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP compliance

Qualifier:

according to guideline

Guideline:

other: OECD Guideline No. 402 (equivalent to Annex V), limit test

GLP compliance:

yes

Limit test:

yes

Species:

rat

Vehicle:

other: None. Liquid applied undiluted.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths :0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths :0

Gross pathology:

Effects on organs:
No treatment-related findings were found at necropsy.

Other findings:

Signs of toxicity (local):
no deaths. Dyspnoea and ruffled fur (slight to moderate) were seen from 1 hour post application to days 9-11.
Other signs were expophthalmus noted on days 2-10 and altered (ventral and/or curved) body position noted on the day of treatment and up to day 6 of observation. No treatment-related cutaneous changes were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Based on the available information in the dossier, the substance 400-830-7 does not need to be classified for acute toxicity when considering the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.