Registration Dossier

Administrative data

Description of key information

The substance is not considered being a skin sensitiser, based on an in-vivio test performed by Buehler et al. applying the free acid rather than the potassium salt at the maximum non-irritant concentration.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read across to in vivo study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance fatty acids, tall-oil, reaction products with acrylic acid potassium salt is the corresponding potassium salt of the source substance fatty acids, tall-oil, reaction products with acrylic acid and manufactured accordingly by neutralisation with potassium hydroxide. As the potassium cation is an essential nutrient for humans it does not contribute to the sensitisation potential; hence, a read-across to the free acids is justified.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance actually is manufactured form the source substance by neutralisation of fatty acids, tall-oil, reaction products with acrylic acid (source substance) with potassium hydroxide, forming the target substance fatty acids, tall-oil, reaction products with acrylic acids potassium salt. The source substance has been registered already and was found not being a skin sensitiser. The potassium cation does not influence sensitisation as it is an essential nutrient for humans and as such does not normally elicit an immunological response.
3. ANALOGUE APPROACH JUSTIFICATION
The structure of the organic moiety of source and target substance is identical and thus read-across form the free acid to its salt is common practice and justified.
4. DATA MATRIX
Not relevant here as organic moieties of source and target substance are identical, and both only do differ by the potassium cation present in the target substance (compared to a proton in the source substance).
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Buehler, EV. Delayed contact hypersensitivity in the guinea pig. Arch Dermat 91, February 1965.
GLP compliance:
no
Remarks:
study conducted prior to GLP
Type of study:
Buehler test
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.
Reading:
other:
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
In a skin sensitisation test according to Buehler, 0.1% Diacid 1550, the free acid of the target substance, being the corresponding potassium salt, in propylene glycol did not induce skin sensitisation in albino guinea pigs under the conditions of this test. Thus, it is concluded that also the potassium salt is not sensitising to skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result from a read-across study for in vivo skin sensitisation, the substance is not considered a skin sensitiser and classification for skin sensitisation is not required according to CLP (Regulation EC No. 1272/2008).