(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Endpoint summary

Description of key information

The substance is not acutely toxic via oral nor dermal route.

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: see 'Remark'

Remarks:

The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 401 (1987) 21 CFR 58 (FDA) C(81)30 (Final) (OECD)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

other: Albino rat

Vehicle:

corn oil

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:

other: Signs of toxicity related to dose levels: Soft stools were noted in 2 females on the day of treatment only. This was not considered as remarkable.

Gross pathology:

Effects on organs:
No remarkable findings.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was not acutely toxic to albino rats (LD50 > 5000 mg/kg) in a OECD 401 (1987) test conducted under GLP. The test result is considered as valid.

Executive summary:

The substance was not acutely toxic to albino rats (LD50 > 5000 mg/kg) in an OECD 401 test conducted under GLP. The test result is considered as valid.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Good (already evaluated by authorities).

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 402 (1987) EEC Directive 84/449 (1984) - Annex V - Method B3 EPA n° 798.1100 (1990) MAFF n° 4200 (1985)

GLP compliance:

yes

Limit test:

yes

Species:

other: Sprague-Dawley rat

Type of coverage:

semiocclusive

Vehicle:

other: Sterile Codex liquid paraffin

Duration of exposure:

24 h

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:

other: Signs of toxicity related to dose levels: None

Gross pathology:

Effects on organs:
None

Other findings:

Signs of toxicity (local):
None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was not acutely toxic to Crl CDBR rats (LD50 > 5000 mg/kg) in a EU B.1 test conducted under GLP. The test result is considered as valid.

Executive summary:

The test substance was not acutely toxic to Sprague-Dawley rats (LD50 > 2000 mg/kg, dermally) in an OECD 402 and EU B.3 test conducted under GLP. The test result is considered as valid.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Good (already evaluated by authorities)

Additional information

Justification for selection of acute toxicity – oral endpoint
A valid GLP study. Another valid supporting study with the same test result.

Justification for selection of acute toxicity – inhalation endpoint
The substance we register as importer is included as an additive in a polymer matrix. The pure substance as such is not available; this route of exposure is not likely.

Justification for selection of acute toxicity – dermal endpoint
A valid OECD 402 and EU B.3 test conducted under GLP. Another valid supporting study with the same test result.

Justification for classification or non-classification

Available GLP studies show consistently that the substance is not acutely toxic via oral nor dermal route.