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Administrative data

Description of key information

Acute toxicity of the test material after single oral, dermal or inhalative administration was determined in non-GLP studies similar to the OECD guidelines 401, 402 or 403, respectively. Administration of the compound by the respective route did not cause mortalitiy or signs of toxicity. LD50 after oral application is > 10.000 mg/kg bw, LD50 after dermal application is considered to be higher than 2500 mg/kg bw. The issue of the inhalation study was to determine an acute inhalation hazard. However, due to an unsuitable test method for non-volatile or non-dusty solids, the study is regarded as invalid.

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (very brief documentation)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(application volume exceeds 20 mL/kg bw, 7 days observation period)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Gassner
- Mean weight at study initiation: males: 229 g (208 - 246 g); females: 170 g (165 - 171 g)

ENVIRONMENTAL CONDITIONS: not reported
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(0.5% aqueous solution)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 35 % suspension in 0.5 % aqueous CMC solution

Doses:
10000 mg/kg bw (28.5 mL/kg bw)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of weighing: day 1, 5 and 8
- Observation of clinical signs: on the day of administration and once daily afterwards (on working days)
- Necropsy of survivors performed: yes
Statistics:
not performed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality was observed.
Clinical signs:
yellow faeces
Body weight:
Mean weight: (day 5): males 262 g, females 182 g; (day 8): males 227 g, females 175 g
Gross pathology:
No abnormalities were observed.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
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 (incomplete documentation, occlusive treatment, 24 h exposure)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(occlusive treatment, 24 h exposure)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga, Ottobrunn, Germany
- Mean weight at study initiation: males 136 g, females 119 g

ENVIRONMENTAL CONDITIONS: not reported
Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% solution in water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal, p.c., 50 cm²
- % coverage: considered to be > 10 % (mean bw of 136 g, calculated with the formula " surface area = 9.1 x bw (exp) 0.67"
- Type of wrap if used: no data
- Site of exposure: dorsal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water containing mild detergent
- Time after start of exposure: no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg bw (5mL/kg bw)
- Concentration (if solution): 50 % suspension solution (in water 0.5% CMC)
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before application
- Frequency of observations: daily (on working days: day 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14)
- Necropsy of survivors performed: yes
Statistics:
not performed
Preliminary study:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no clinical signs were observed.
Mortality:
No mortality ocurred.
Clinical signs:
No clinical signs were observed.
Body weight:
no data
Gross pathology:
No abnormalities were observed.
Other findings:
- Other observations: after 24 h and 8 days: local yellow substance residues
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 500 mg/kg bw

Additional information

Oral:

Acute oral toxicity of the test item, dissolved in an aqueous solution 0.5% CMC, was determined by single oral (gavage) administration to male and female rats at a concentration of 10.000 mg/kg bw. The animals were observed for 7 days and checked for mortality, body weight change and clinical signs of toxicity. All animals survived until scheduled day of necropsy which did not reveal any findings. Excretion of yellowish feces was reported.

Dermal:

To determine acute dermal toxicity of the test substance, 2500 mg/kg bw of the material was applied onto dorsal skin of male and female rats for 24h under occlusive conditions. The animals were observed for 14 days and checked daily for mortality and clinical signs of toxicity. None of the rats died; yellowish staining of the treatment site was observed.

Inhalation:

Furthermore, acute inhalation toxicity and toxicity after intraperitoneal injection was examined. Exposure of 12 rats for 8h to an atmosphere enriched with the test material did not cause mortality or findings in necropsy.

Other routes:

Intraperitoneal injection of an aqeous solution of the test substance (10.000 mg/kg bw) into mice did not result in mortalities. Intra-abdominal deposits of test substance and conglutinations were observed during necropsy.

Results and discussion

Single oral or dermal administration of the test substance did not cause mortality; signs of toxicity were also not observed. LD50 after oral or dermal application is therefore considered to be higher than 10.000 or 2500 mg/kg bw, respectively.

The test method to determine inhalation toxicity was not suitable for non-volatile solids. Moreover, concentration and composition of the test atmosphere was not analytically examined. Nonetheless, the study demonstrates that exposure to an enriched atmosphere did not cause acute toxicity. Injection of the substance does not represent a relevant route of exposure. Regarding human health and safety, the result of the study bears no suitable information.

Justification for classification or non-classification

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 toxicity under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) No 2017/776.