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Administrative data

Description of key information

Oral LD50 > 500 mg/kg bw, dermal LD50 > 1000 mg/kg bw

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
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
equivalent or similar to
Guideline:
other: U.S. 52 FR 42961, 49 CFR 173.132
Principles of method if other than guideline:
This study was performed under the DOT guidelines specified in 52 FR 42961, 49 CFR 173.132
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Albino rats, five males and five females
All weighed between 200 and 300g
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All rats were administered a single Sponsor specified dose of the test substance by oral gavage.
Doses:
500 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
All animals received a single dose of 500 mg/kg bw of the test substance by oral gavage. The dose volume did not exceed 1 ml/100 g body weight. Following treatment, the animals were observed for clinical signs of toxicity at least once daily for 14 days. Body weights were determined on Day 0, Day 7, and Day 14.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
test mat.
Mortality:
1 rat died on Day 2 of the observation period.
Clinical signs:
Two of the test animals exhibited clinical signs
Body weight:
All surviving animals exhibited body weight gain by day 14
Gross pathology:
The animal that died during the study was observed at necropsy as having a moderately pale liver. All other animals were observed as having no visible lesions at necropsy

The oral LD50 of the test material is ≥500 mg/kg bw according to a U.S. DOT guideline study.

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
> 300 mg/kg as per Regulation EC No. 1272/2008
Conclusions:
The oral LD50 of the test material is greater than 500 mg/kg bw in rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
500 mg/kg bw
Quality of whole database:
adequate

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
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
equivalent or similar to
Guideline:
other: U.S. 52 FR 42961, 49 CFR 173.132
Principles of method if other than guideline:
This study was performed under the DOT guidelines specified in 52 FR 42961, 49 CFR 173.132
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Ten albino ratts (5 male and 5 female) were used in the study
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Dorsums were clipped free of hair prior to application of the test article. The test article was introduced to not less than 10% of the total body surface area (15.5cm x 15.5cm) The test article was held in contact with the skin with prous gauze dressing and non-irritating tape. The animals were further wrapped with Vetrap bandaging for the exposure period.
Duration of exposure:
24 hours
Doses:
1000 mg (1 g)/kg bw, as specified by sponsor
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The duration of the occlusive exposure was 24 hours. At the end of the exposure period, the test sites were rinsed with water and the animals observed for signs of erythema and edema. The animals were then observed daily for clinical signs of toxicity for a 14 day observation period. At the end of the observation period, a gross necropsy was performed on all animals.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
The LD50 may be > 2000 mg/kg bw
Mortality:
None observed
Clinical signs:
No signs of toxicity were observed in any of the animals. However, erythema was noted on all animals after the 24h exposure period and was reversed on all animals by Day 5.
Body weight:
All animals gained weight during the course of the study.
Gross pathology:
No unusual observation recorded in gross pahtologies.

Erythema was noted on all animals after the 24h exposure period, but resolved in all animals by day 5.

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 of the test material is > 1000 mg/kg bw, with no observed lethality for 14 days after exposure. This was evaluated as "non-toxic" according to the U.S. DOT guidelines.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
1 000 mg/kg bw
Quality of whole database:
adequate

Additional information

Justification for classification or non-classification

The substance has an oral LD50 > 500 mg/kg bw; this meets the criteria for classification as acute oral toxicity 4 (300 mg/kg > LD50 < 2000 mg/kg). The dermal LD50 is > 1000 mg/kg bw and evaluated as "non-toxic" with lethality reported, though this single dose is not sufficiently high to meet GHS requirements for non-classification. Due to the absence of any animal deaths at 1000 mg/kg bw, and the evaluation of "non-toxic" according to U.S. DOT guidance, the substance is not classified for acute toxicity by the dermal route. However, due to an indication of skin irritation and severe damage to the eye, protection from dermal exposure is recommended by the use of personal protective equipment.