A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates

Endpoint summary

Description of key information

LD50 (oral): >2,000 mg/kg bw (Annex V (B1), GLP)
LD50 (dermal): >2,000 mg/kg bw (Annex V, 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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Annex V,B1

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

other: Rat(Tif:RAI)

Vehicle:

arachis oil

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

Clinical signs:

Signs of toxicity related to dose levels:
Piloerection, hunched posture and dyspnea folliowing administration.

Body weight:

effects on organs:
No treatment-related effect observed.

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 number 06-2120047284-59-0000 ,permission to refer granted by ECHA

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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: Comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Annex V

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif:RAI

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24h

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Mal曰: 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

Clinical signs:

Signs of toxicity related to dose levels:
Piloerection, abnormal body positions and dysprea observed in all animals.

Gross pathology:

Effects on organs:
No abnormality observed

Other findings:

Signs of toxicity (Iocal):
None

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 number 06-2120047284-59-0000 ,permission to refer granted by ECHA

Additional information

Acute Toxicty: Oral

Two acute oral toxicity studies carried out in rats were available.

In the key acute oral toxicity study carried out in male and female Sprague Dawley rats, (Annex V (B1), GLP) the LD50 was determined to be > 2000 mg/kg bw. Mortalities were not evident in either sex at any dose. The clinical signs of toxicity following administration were piloerection, hunched posture and dyspnea.In the supporting acute oral toxicity study carried out in male and female Sprague Dawley rats, (84/449/EEC, (B.1)), GLP) the LD50 was determined to be > 2000 mg/kg bw. Mortalities were not evident in either sex at any dose. Unspecific signs of poisoning, reversible within 4 days were noted in the case of all animals. The key study was chosen as the study with the most specific results provided. The LD50 value >2000mg/kg bw from the key study was chosen as the key value for the acute oral toxicity endpoint.

Acute Toxicty: Dermal

Two acute dermal toxicity studies carried out in rats were available.

In the key acute dermal toxicity study carried out in 5 male and 5 female rats (Tif:RAI) (Annex V/GLP, semi-occlusive application, 2000mg/kg bw), no deaths occurred. Clinical signs of toxicity in all animals were piloerection, abnormal body positions and dysprea. No signs of local toxicity were observed. The LD50 value was >2000mg/kg bw. In the supporting acute dermal toxicity study carried out in 5 male and 5 female rats (Tif:RAlf (SPF) (84/449/EEC B.3/GLP, semi-occlusive application in diluted form, 2000mg/kg bw), no deaths occurred. There were unspecific signs of poisoning, reversible within 5 days in the case of all animals and no signs of local toxicity were observed. The key study was chosen as the study with the most specific results provided. The LD50 value >2000mg/kg bw from the key study was chosen as the key value for the acute dermal toxicity endpoint.

Justification for selection of acute toxicity – oral endpoint
There is more information provided in the results of the key study.

Justification for selection of acute toxicity – dermal endpoint
There is more information provided in the results of the key study.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Chiguard 5599 (CAS No. 127519-17-9) does not need to be classified for acute toxicity or STOT-SE when the criteria outlined in Annex I of 1272/2008/EC are applied.