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Description of key information

Acute oral toxicity: No study with HiMoLABS is available. The supporting substance H220 Na displayed an LD50 value >2000 mg/kg and is therefore considered to not be classi

Acute oral toxicity: as the test substance is classified as corrosive to the skin and eyes, no acute oral toxicity study is required.

Acute inhalation toxicity:

acute dermal toxicity:

Acute dermal toxicity:

Acute oral toxicity: No acute oral toxicity is available with HiMoLABS. The substance is considered not to be classified as acute oral toxicant with LD50 greater than 2000 mg/kg based on category approach (read across from H220 Na).

Acute inhalation toxicity: In accordance to column 2 of REACH Annex VIII, no acute inhalation toxicity study is available as there are key studies via the oral and the dermal route of exposure.

Acute dermal toxiciy: No acute dermal

The acute oral median lethal dose (LD50) of test substance H220 Na in the rat was estimated to be > 2000mg/kg.

The oral LD50 value for the substance HiMo LABS is therefore considered to be >2000 mg/kg bw.
Acute dermal LD50 value for LAB was established as greater than 2000 mg/kg bw.

The acute dermal LD50 of the test substance HiMoLABS is therefore considered to be > 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The justification on the read across analogue approach is included in IUCLID 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality
Interpretation of results:
GHS criteria not met
Conclusions:
The supporting analogue substance HiMo LABS C10-12 displayed an LD50 value > 2000.0 mg/kg bw. Therefore, the target substance is considered not to be classified according to CLP regulation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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 the substance is classified as corrosive to the skin
other:
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:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification document on the read across category approach is included in IUCLID 13.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: undiluted
Interpretation of results:
GHS criteria not met
Conclusions:
Based on two reliable studies with category substances LAB and LABS Na, the test substance is assumed to have a dermal LD50 value > 2000 mg/kg. Therefore the substance is considered not to be classified according to the CLP Regulation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

There are no specific studies performed with the target substance.

Acute oral toxicity:

An acute toxicity study with HiMo LABS C10 -12 was conducted according to OECD guideline 425 in rats. the LD50 was determined to be greater than 2000 mg/kg. Therefore the test substance is considered to not be classified according to CLP Regulation. Moreover, as the test substance is classified as corrosive to the skin and eyes, no acute oral toxicity study would be required according to REACH Regulation column 2 adaptation.

 

Acute inhalation toxicity:

As the test substance is classified as corrosive to the skin and eyes, no acute inhalation toxicity study is required according to the REACH regulation column 2 adaptation.

                                  

Acute dermal toxicity:

No study on acute toxicity via dermal administration is available with the target substance. Data generated with category substances LAB and LABS Na was considered the pivotal datasets for this endpoint.

Acute dermal toxicity of LAB was determined in 5 male and 5 female rats, according to OECD guideline 402. LAB was administered via dermal application at 2000 mg/kg bw and exposure lasted 24hrs, after which the test substance LAB was removed by washing. During a 14-day observation period, no mortality was observed. Nine out of 10 animals developed a slightly raised red area at the dose site 1 week after exposure, which turned into scabs at day 9 of the observation period. All animals fully recovered by the end of the study. The dermal LD50 of LAB in rats is considered to be above 2000 mg/kg bw.

Acute dermal toxicity of LABS Na was determined in 5 male and 5 female rats, according to OECD guideline 402. LABS Na was administered via dermal application at 2000 mg/kg bw and exposure lasted 24hrs, after which the test substance LABS Na was removed by washing. During a 14-day observation period, no mortality was observed. There were no signs of systemic toxicity, but reversible signs of slight erythema and slight edema were noted. The dermal LD50 of LABS Na in rats is considered to be above 2000 mg/kg bw.

Justification for classification or non-classification

The target substance is considered not be classified as acute oral toxicant or acute dermal toxicant according to the CLP regulation. No acute inhalation study is available.

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