Registration Dossier

Administrative data

Description of key information

- LD50 acute oral toxicity (male; rat): > 10000 mg/kg bw (reliability score: 2)
- LD50 acute dermal toxicity (male; rabbit): > 5000 mg/kg bw (reliability score: 2)

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:
other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity, only males tested)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(limited documentation, maximal applicated volume > 20mL/kg bw)
Principles of method if other than guideline:
5 male rats per group fasted for 24 h were dosed with a 10% aqueous dispersion of the test substance. Signs of intoxication were documented and animals were necropsied at study termination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 153 g
- Fasting period before study: 24 h
Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%

MAXIMUM DOSE VOLUME APPLIED: 100 mL/kg bw

Doses:
10,000; 5,000; 2,500; 1,250 mg/kg bw
No. of animals per sex per dose:
5 (only males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: no data
- Frequency of weighing: at initiation and termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred in the highest dose group.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the observation period.
Body weight:
Mean body weight (study initiation; study termination):
- 10000 mg/kg bw: 152; 255
- 5000 mg/kg bw: 153; 256
- 2500 mg/kg bw: 153; 257
- 1250 mg/kg bw: 154; 266
Weight gains were comparable in all dose groups.
Gross pathology:
Necropsy revealed no substance-related findings.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
10 000 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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(limited documentation, occlusive treatment), dose of 5000 mg/kg bw
Principles of method if other than guideline:
10 male rabbits were treated with a paste, prepared with the test substance and diethyl succinate, for 24 h under occlusive conditions. The skin was shaved before application. Signs of intoxication as well as skin irritation were documented and animals were necropsied at study termination.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data
Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Further characterisation: Albino rabbits
- Mean weight at study initiation: 2.88 kg
Type of coverage:
occlusive
Vehicle:
other: diethyl succinate
Details on dermal exposure:
REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 5000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (only males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: no data
- Frequency of weighing: at initiation and termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the observation period.
Body weight:
Mean weight (study initiation; study termination):
- 5000 mg/kg bw: 2.88 kg; 3.13 kg
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
Skin irritation:
Well-defined erythema were observed.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw

Additional information

Acute Oral Toxicity  

In a standard acute oral toxicity study performed similarly to OECD TG 401, groups (5 male rats/dose) of young Wistar rats were administered the test substance (no data on purity) after a 24 h fasting period. The test substance was administered at doses of 1,250, 2,500, 5,000 and 10,000 mg/kg bw in water. Animals were subsequently observed (no data on duration of observation) and clinical signs of toxicity, body weight changes and cases of mortality were noted.

Deaths did not occur at any dose level. Hence the LD50 is higher than 10,000 mg/kg bw. There were no treatment related clinical signs of toxicity, necropsy findings or changes in body weight.

 

This study is suitable for assessment of acute oral toxicity as it was performed using a protocol which is similar and equivalent to the deleted OECD guideline (401). Because of the high doses applied that did not induce mortality in males it can be assumed that treatment of females would not have caused mortality, either. The documented weight changes indicate an adequate observation period duration.

 

Acute Dermal Toxicity

In an acute dermal toxicity study a group of 10 male Albino rabbits were dermally exposed to the test substance (no data on purity) in diethyl succinate for 24 hours at a limit dose of 5,000 mg/kg bw and observed (no data on duration of observation) after treatment. Death did not occur. Hence the LD50 is higher than 5,000 mg/kg bw. Except well-defined erythema as an irritating effect, there were no treatment related clinical signs of toxicity, necropsy findings or changes in body weight.

 

This study is suitable for assessment of acute dermal toxicity as it was performed using a protocol which is similar and equivalent to the OECD guideline. The weight gain of the animals indicates an adequate observation period, although the information on duration is lacking. Due to the high LD 50 it can be presumed, that no female would have died, either.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, classification for acute toxicity is not warranted.

 

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

The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013, classification for acute toxicity is not warranted.