Registration Dossier

Administrative data

Description of key information

LD50 Oral: >2000mg/kg bw (OECD 401, GLP)
LD50 Dermal: >2000mg/kg bw (OECD 402, 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: OECD guideline study-GLP compliance
Qualifier:
according to
Guideline:
other: Method B1 of 92/69 EEC and OECD 401
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: rat (Sprague-Dawley)
Sex:
male/female
Vehicle:
arachis oil
Doses:
Males: 2000 mg/kg bw
Females: 2000 mg/kg bw
Details on study design:
5 males
5 females
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::
No signs of systemic toxicity were observed during the observation period.
Gross pathology:
Effects on organs: No abnormalities were observed at necropsy.
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

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: OECD guideline study-GLP compliance
Qualifier:
according to
Guideline:
other: Method B3 of 92/69/EEC and OECD 402
GLP compliance:
yes
Limit test:
yes
Species:
other: Sprague-Dawley
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
other: None
Duration of exposure:
24 hours
No. of animals per sex per dose:
5 males
5 females
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 level:
No signs of systemic toxicity observed.
Gross pathology:
Effects on organs: No abnornmalities were observed at necropsy.
Other findings:
Signs of irritation (local):
No signs of irritation 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

Additional information

Acute Toxicity:Oral 

In acute oral toxicity studies carried out in 10 male/10 female and 5 male/5 female animals (Annex V guideline limit tests, 5000mg/kgbw) the LD50 was determined to be >5000mg/kg bw. In two further acute oral toxicity studies carried out in 5 male and 5 female animals (guideline limit tests, 2000mg/kg bw) the LD50 was determined to be >2000mg/kg bw. As one of these tests was carried out in accordance with OECD 401/GLP, it was chosen as the key study and the LD50 value >2000mg/kg bw was chosen as the key value for the acute oral toxicity endpoint.

Acute Toxicty: Dermal

In two acute dermal toxicity studies carried out in 5 male and 5 female animals (guideline limit tests, occlusive and semi-occlusive application, 2000mg/kg bw), no deaths occurred and no signs of toxicity were observed. No signs of local toxicity were observed in either study. As one of these tests was carried out in accordance with OECD 402/GLP, it was chosen as the key study and the LD50 value >2000mg/kg bw was chosen as the key value for the acute dermal toxicity endpoint.

Justification for classification or non-classification

Based on the available information in the dossier, the substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) does not need to be classified for acute toxicity when the criteria outlined in Annex I of 1272/2008/EC are applied.