Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 30 minutes. The hydrolysis products have been identified to be triethanolamine and zirconium dioxide. The discussion of toxiciy is based on the hydrolysis/degradation products.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
triethanolamine is the main hydrolysis prodcuts of the target substance. Properties of the the hydrolysis substance are used for read-across.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
No. of animals per sex per dose:
Not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 190 - < 11 260 mg/kg bw
Based on:
test mat.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The oral LD50 on rats was 4190 to 11260 mg/kg bw, and was classified as Category 5 according ly GHS criteria.
Executive summary:

As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 190 mg/kg bw

Acute toxicity: via inhalation route

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Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 30 minutes. The hydrolysis products have been identified to be triethanolamine and zirconium dioxide. The discussion of toxicokinetics is based on the hydrolysis/degradation products.
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
The target substance is a viscous liquid with viscosity over 25000 mPa.s at 25°C. The hydrolysis product, triethanolamine, is also a viscous liquid with vapour pressure less than 1.3 Pa at 25°C. Therefore, exposure via inhalation is unlikely.
Reason / purpose:
exposure-related information
Reason / purpose:
exposure-related information
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 30 minutes. The hydrolysis products have been identified to be triethanolamine and zirconium dioxide. The discussion of toxicokinetics is based on the hydrolysis/degradation products.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0
Clinical signs:
TEA elicited mild erythema and no edema at 24 h and the skin returned to normal by Day 6. The 91.8% TEA produced moderate erythema and no edema at 24 h and the treated sites were normal by Day 10.
Body weight:
The animals were observed for 14 days. All rabbits gained weight and none died.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The dermal LD50 on rabbits was greater than 2000 mg/kg bw, and was classified as Category 5 according ly GHS criteria.
Executive summary:

As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification