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Administrative data

Description of key information

This substance is an amphoteric surfactant and has uses in the Cosmetics industry. Under the cosmetics regulation, animal testing is not allowed on substances used in such products. There is no available in-vivo acute oral toxicity data for this substance and none can be generated.

Data has been found relating to similar UVCB substances in published review documents for alkyl imidazolines and imidazoline derivatives

suggest that these substances are of low oral toxicity and pose little concern for human health. One set of data suggest that the level may be just below the 2000 mg/kg/bw limit for no classification, where the other set of data suggest that the level is >5000 mg/kg/bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
other: not specified
Specific details on test material used for the study:
Alkyl imidazoline is a UVCB material contininag structures which are very similar to the substance under test.
There are no studies for this substance and due to a ban on animal testing for such end points, it is necessry to try to find an alternative way of making an assessment using other substances that have been tested in-vivo in previous years.
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Sex:
female
Dose descriptor:
LD50
Effect level:
> 1 213 - <= 2 546 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 1 259 - <= 2 638 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 1 515 - <= 2 349 mg/kg bw

Alkyl imidazoline, 1-(2-Hydroxyethyl)-2-alkyl*-2-imidazoline (*as in fatty acids of tall oil), has been tested in the following acute toxicity

tests. With Sprague-Dawley rats (MRID No. 42293001), alkyl imidazoline demonstrated an acute oral LD of 1948 (1259-2638) mg/kg body weight 50 for male rats, 1880 (1213-2546) mg/kg for female rats, and 1932 (1515 - 2349) mg/kg for combined sexes.

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Alkyl imidazoline is a UVCB material contininag structures which are very similar to the substance under test.
There are no studies for this substance and due to a ban on animal testing for such end points, it is necessry to try to find an alternative way of making an assessment using other substances that have been tested in-vivo in previous years.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Specific details on test material used for the study:
The amphoteric surfactants in this group include structures designated as alkylamphoacetates, alkylamphopropionates, and alkyliminopropionates. These surfactants are usually produced by the reaction of fatty acids or their esters with amines (e.g. aminoethylethanol amine). Alkylamphopropionates may be obtained by the addition of acrylic acid, methyl acrylate, or ethyl acrylate to the reaction product of fatty acids and amines. During the synthesis of most of the surfactants an intermediate imidazoline ring structure may be formed (hence the common name ‘imidazoline derivatives’). The imidazoline ring is probably opened by the influence of hydrolysing conditions and does not appear in the final products (Domsch 1995).
Species:
rat
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
In-vivo acute oral toxicicty data that are available for these imidazoline derivatives suggest that these substances are of low oral toxicity and pose no concerns for human health.
Endpoint:
acute toxicity: oral
Data waiving:
study waived due to provisions of other regulation
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification