Registration Dossier

Administrative data

Description of key information

Toxicity (Oral): LD 50 = >5000 mg/kg bw (OECD 401; GLP)
Toxicity (Dermal): LD 50 = >2000 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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD method, GLP compliance
Reference:
Composition 0
Qualifier:
according to
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
Test material information:
Composition 1
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:
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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Information from migrated NONS file, as per inquiry number 06-0000020961-70-0000, permission to refer granted by ECHA

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Annex V Guideline study with GLP compliance
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
yes
Test material information:
Composition 1
Species:
other: Rat (Sprague Dawley)
Type of coverage:
semiocclusive
Vehicle:
other: The substance as supplied was applied to skin which was moistened with arachis oil B.P.
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:
Signs of toxicity related to dose levels:
No signs of systemic toxicity were noted during the study period. No toxicologically significant effects on bodyweight were noted during the study.
Gross pathology:
Effects on organs: No abnormalities were noted at necropsy of animals killed at the end of the study.
Other findings:
Signs of toxicity (local):
No signs of dermal irritation were noted during the study period.
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
2 000 mg/kg bw
Quality of whole database:
Information from migrated NONS file, as per inquiry number 06-0000020961-70-0000, permission to refer granted by ECHA

Additional information

Acute Toxicty: Oral

Two acute oral toxicity studies in the rat were available. In the supporting study (Annex V B1, GLP), there were no mortalities and no treatment-related clinical signs; the LD50 was >5000 mg/kg bw. In the acute oral toxicity key study (OECD 401/GLP), groups of rats (Albino; 5/sex) were given a single oral dose of Flyadd-3 in corn oil at a dose of 5000 mg/kg bw.

Oral LD50 Males/Females = >5000 mg/kg bw

No deaths were observed and there were no other treatment-related effects noted. The LD50 value for the acute oral toxicity endpoint is >5000mg/kg bw.

Acute Toxicity: Dermal

Two acute dermal toxicity studies in the rat were available. In the supporting limit test study (OECD 402, GLP) groups of rats (Sprague Dawley; 5/sex) were dermally exposed (semi-occlusive) to the test substance in liquid paraffin for 24 hrs at a dose of 2,000 mg/kg bw. No deaths occurred and no signs of toxicity (systemic or local) were observed.

In the acute dermal toxicity key study (Annex V/GLP), groups of rats (Sprague Dawley; 5/sex) were dermally exposed (semi-occlusive) to the test substance (skin was moistened with arachis oil B.P.) for 24 hrs at a dose of 2,000 mg/kg bw.

Dermal LD50 Males/Females = >2,000 mg/kg bw

No deaths occurred and no signs of toxicity (systemic or local) were observed. There were no toxicologically significant effects on bodyweight and no abnormalities were noted at necropsy of animals killed at the end of the study. The LD50 value for the acute dermal toxicity endpoint is >2000mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only 1 key study available

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH annex VIII, the information under 8.5.2 and 8.5.3 shall be provided for at least one other route in addition to the oral route. As there is already information about 8.5.1 and 8.5.3, the acute inhalation test does not need to be conducted.

Justification for selection of acute toxicity – dermal endpoint
Although the supporting study was OECD guideline and GLP compliant, there was brief supporting documentation that was inconsistent. The key study chosen was an Annex V guideline study with GLP compliance which provided a clear description of the study results.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Flyadd-3 (CAS No. 135861-56-2) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC) are applied.