Registration Dossier

Administrative data

Description of key information

oral (rat): > 5000 mg/kg bw (m+f) (no mortality observed)

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:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Source of report or test material: UniroyalChemical Company Middlebury, CT
Label: Polylite
Description: Dark brown liquid
The test article was stored in the container provided by the sponsor at ambient room temperature and humidity
Specific gravity: 0.93
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: No data
- Weight at study initiation: 284-297g for males and 235-255 g for females.
- Fasting period before study: 16-24h
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Aug 7, 1981 To: Aug 21, 1981
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The rats were observed twice daily for 14 days for mortality and toxicity. Body weights were recorded pretest, weekly and at death. All rats were examined for gross pathology.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
None
Clinical signs:
Anogenital area stained brown (two females during two days)
Chrornodacryorrhea (each one male and one female during one day)
Dyspnea (one male during two days)
Ptosis (one female during one day)
Chromorhinorrhea (one male during one day)
Body weight:
No changes
Gross pathology:
One animal had parts of the intestine with a yellow coloration.
Interpretation of results:
GHS criteria not met
Conclusions:
No mortality was observed at a single dose of 5000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 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
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The substance was tested in male and female Wistar rats for its acute oral toxicity at a limit dose of 5000 mg/kg bw. The study design is comparable to that of OECD testing guidelines for acute oral toxicity (ie 14 days observation period, recording of body weights, clinical signs and gross necropsy findings). Rats showed transient clinical signs. All animals survived the observation period.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal or inhalation toxicity under Regulation (EC) No. 1272/2008.