Registration Dossier

Administrative data

Description of key information

Based on a Buehler test propan-2-ol was determined not to be skin sensitising (reference 7.4.1 -1).

Based on a guinea pig maximaisation test Methylacrylic acid was determined not to be skin sensitising (reference 7.4.1 -2).

Based on a guinea pig maximaisation test chromium trichloride was classified as skin sensitiser (reference 7.4.1 -3).

Therefore, the test item, which is a complex of propane-2-ol, chromium trichloride and methylacrylic acid is determined to be skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance is a complex consisting of propane-2-ol, chromium trichloride and methylacrylic acid. Studies on skin sensitisation were not performed for the target substance. Reliable experimental data are available for the three components, propane-2-ol, chromium trichloride and methylacrylic acid, which are considered to be suitable read across substances.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance propane-2-ol (CAS: 67-63-0) is already registered under REACH. A guinea pig maximisation test was performed to determine its sensitising potential without documentation of the substance purity. The target substance tetrachloro-μ-hydroxy(μ-methacrylato-O:O')dichromium (CAS 15096-41-0) is a complex containing propane-2-ol, chromium trichloride and methylacrylic acid.

3. ANALOGUE APPROACH JUSTIFICATION
Experimental data i.e. skin sensitisation studies in the guinea pig are available for propane-2-ol, chromium trichloride and methylacrylic acid. The guinea pig maximaisation test on propane-2-ol was performed according to OECD guideline 406. The assay is considered to be reliable and well documented. Skin sensitisation study on chromium trichloride and methylacrylic acid were also performed in guinea pigs. Those studies were performed similar to OECD guideline 406. The information given on the three single components is considered to be sufficient to cover the required endpoint information for the complex thereof.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Group:
positive control
Remarks on result:
not measured/tested
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance is a complex consisting of propane-2-ol, chromium trichloride and methylacrylic acid. Studies on skin sensitisation were not performed for the target substance. Reliable experimental data are available for the three components, propane-2-ol, chromium trichloride and methylacrylic acid, which are considered to be suitable read across substances.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance chromium trichloride (CAS: 10025-73-7) is already registered under REACH. A guinea pig maximisation test was performed to determine its sensitising potential without documentation of the substance purity. The target substance tetrachloro-μ-hydroxy(μ-methacrylato-O:O')dichromium (CAS 15096-41-0) is a complex containing propane-2-ol, chromium trichloride and methylacrylic acid.

3. ANALOGUE APPROACH JUSTIFICATION
Experimental data i.e. skin sensitisation studies in the guinea pig are available for propane-2-ol, chromium trichloride and methylacrylic acid. The guinea pig maximaisation test on chromium trichloride was performed similar to OECD guideline 406. The assay is considered to be reliable. Skin sensitisation study on propane-2-ol and methylacrylic acid were also performed in guinea pigs. Those studies were performed according to or similar to OECD guideline 406. The information given on the three single components is considered to be sufficient to cover the required endpoint information for the complex thereof.
Reason / purpose for cross-reference:
read-across source
Challenge controls:
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2 mg/mL
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
inflammatory skin reaction
Remarks on result:
positive indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Group:
negative control
Remarks on result:
not measured/tested
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance is a complex consisting of propane-2-ol, chromium trichloride and methylacrylic acid. Studies on skin sensitisation were not performed for the target substance. Reliable experimental data are available for the three components, propane-2-ol, chromium trichloride and methylacrylic acid, which are considered to be suitable read across substances.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance methylacrylic acid (CAS: 79-41-4) is already registered under REACH. A guinea pig maximisation test was performed to determine its sensitising potential without documentation of the substance purity. The target substance tetrachloro-μ-hydroxy(μ-methacrylato-O:O')dichromium (CAS 15096-41-0) is a complex containing propane-2-ol, chromium trichloride and methylacrylic acid.

3. ANALOGUE APPROACH JUSTIFICATION
Experimental data i.e. skin sensitisation studies in the guinea pig are available for propane-2-ol, chromium trichloride and methylacrylic acid. The guinea pig maximaisation test methylacrylic acid was performed similar to OECD guideline 406. The assay is considered to be reliable. Skin sensitisation study on propane-2-ol and chromium trichloride were also performed in guinea pigs. Those studies were performed according to or similar to OECD guideline 406. The information given on the three single components is considered to be sufficient to cover the required endpoint information for the complex thereof.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
all dose levels
No. with + reactions:
2
Total no. in group:
25
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
all dose levels
No. with + reactions:
1
Total no. in group:
25
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
all dose levels
No. with + reactions:
1
Total no. in group:
25
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
2
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
all dose levels
No. with + reactions:
0
Total no. in group:
25
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
all dose levels
No. with + reactions:
1
Total no. in group:
25
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
all dose levels
No. with + reactions:
0
Total no. in group:
25
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Key result
Group:
positive control
Remarks on result:
not measured/tested
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Buehler test on propan-2-ol (reference 7.4.1-1)

To investigate the skin sensitisating potential of propan-2-ol a Buehler test was performed. The test was performed with 20 guinea pigs in the test group and 10 guinea pigs in the control group. Animals of the test group were treated with undiluted test item for a period of 6 hours weekly for 3 induction exposures. The test animals and control animals were challenged with undiluted Isopropyl alcohol. No skin reactions were observed in the test and control animals therefore, it was concluded that the test item is not a skin senstiser.

GMPT on chromium trichloride (reference 7.4.1-2)

To investigate the skin sensitisating potential of chromium trichloride a guinea pig maximisation test was performed. Guinea pigs were exposed by five injections of 0.2 mL each of an emulsion containing either 2 mg/mL chromium chloride in Freund’s complete adjuvant (FCA) into the footpad and nape of the neck. The animals were restimulated once a week by intradermal injections of 25 µg of chromium chloride. Simultaneously, 0.02 mL of 0.5% chromium chloride in 1% Triton X-100 was applied epicutaneously to the skin of the opposite flank. The boosting was continued weekly until a positive reaction was observed. Four to six weeks after the positive skin reaction had emerged, the animals were challenged epicutaneously, and skin inflammation was evaluated 24 h later. Seven of the ten animals responded to the challenge and inflammatory skin reactions were observed. The test item was determined to be skin sensitising.

GMPT on methylacrylic acid (reference 7.4.1-3)

To investigate the skin sensitisating potential of methylacrylic acid a guinea pig maximisation test was performed. Guinea pigs were exposed by 3 pairs of injection (1. 1:1 mixture (w/w) FCA/water; 2. Test item in vehicle at specific concentration; 3. Test item at the double of specified concentration formulated in a mixture in a 1:1 mixture (w/w) FCA). On day 6 skin areas, used for intradermal injection, were treated with 0.5 g sodium lauryl phosphate (10 %) in petrolatum) and on day 7 0.25 mL of the test substance was applied undiluted for 48 hours with an occlusive dressing. The challenge (day 20) and rechallange (day 27) exposure was performed with 15 - 30 µL of the test item for 24 hours. At challange two animals in the control group and four other animals scattered in the tets groups gave positive reactions. At a rechallenge none of the animals expect one after 48 hours obtained a score for sensitisation. No dose response relationship was found. The test item was determined not to be skin sensitising.

Conclusion

The test item consists of the three different components propane-2-ol, chromium trichloride and methylacrylic acid. Guinea pig maximization tests were performed on all three components. The studies on propane-2-ol and methylacrylic acid revealed no skin sensitizing potential. Chromium trichloride was determined to be skin sensitising. Therefore, the test item was determined to be skin sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is considered to be classified for skin sensitisation (Cat 1B, H317) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.