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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation: negative (not sensitising)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-12-09 to 2009-03-09
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
- supplier: Elevage Charles RIver (F-69592 L'ARBRESLE)
- acclimatation period: 5 days
- weight: 302 and 385 g at the beginning of the test
Positive control results:
alpha hexylcinnamaldehyde at 50% : between 60% and 100% of animals sensitized after 24h
alpha hexylcinnamaldehyde at 50% : between 50% and 90% of animals sensitized after 48h
alpha hexylcinnamaldehyde at 50% : between 51% and 100% of animals sensitized after 24h
alpha hexylcinnamaldehyde at 25% : between 60% and % of animals sensitized after 48h
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 11.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 11.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 11.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 11.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In view of the results, under the experimental conditions described, the test product must no be classified in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C Directives 67/548, 2001/59 and 99/45. In accordance with the Globally Harmonized System (Regulation EC N° 1272/2008), the test product must not be classified in category 1..
Executive summary:

The aim of the study was to evaluate the possible allergenic activity of the test substance after intradermic injection and topical administration in guinea pigs. After induction (intradermic injection at 3.125% and topical application at 50 and 100%) of 11 Guinea Pigs of treated group with the test product and a 10-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product diluted at 50% and at 100%. The experimental protocol was established according the O.E.C.D. guideline n°406 dated July 17th, 1992 and the method B.6 of the council regulation N° 440/2008.

No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item. It was recorded a slight erythema in 9% (1/11) of the animals from the treated group, 24 and 48 hours after the challenge phase, on the treated area at 100%. No cutaneous intolerance reaction was recorded in animals from the negative control group. In conclusion, in view of these results, under these experimental conditions, the test substance needs not be classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required.

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2001-02-15
Reliability:
1 (reliable without restriction)
Qualifier:
no guideline available
Principles of method if other than guideline:
Marzulli and Maibach protocol was followed:
3 phases were followed: induction, rest and challenge phases.
Induction phase corresponding to 9 consecutive occlusive applications for 48 to 72 hours during 3 weeks.
Rest phase corresponding to a 2 week rest period with no application.
Challenge phase corresponding to a 48 hour occlusive application.
Scorings of the skin reaction were performed 30 minutes after removal of the patch and until 48 hours for the challenge phase.
GLP compliance:
no
Type of study:
patch test
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
All subjects included in the study belong to ASTER volunteers' panel. They have been recruited by cooptation of mouth and selected after a careful clinical examination carried out by one of ASTER's physicians
49 subjects: 40 female subjects and 9 male subjects
The mean age of the subjects was 39 (min: 21 and max: 68).
All subjects were considered as healthy following a physical examination done before the start of the study.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% in formulation
No. with + reactions:
8
Total no. in group:
49
Clinical observations:
7/49 with skin reaction level 0.5 and 1/49 with level 1.5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in formulation. No with. + reactions: 8.0. Total no. in groups: 49.0. Clinical observations: 7/49 with skin reaction level 0.5 and 1/49 with level 1.5.
Reading:
2nd reading
Hours after challenge:
96
Group:
test chemical
Dose level:
5% in formulation
No. with + reactions:
1
Total no. in group:
49
Clinical observations:
1/49 with skin reaction level 0.5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. Dose level: 5% in formulation. No with. + reactions: 1.0. Total no. in groups: 49.0. Clinical observations: 1/49 with skin reaction level 0.5.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test substance formulated at 5% in an emulsiont did not induce sensitization reaction. About irritation, the Global Irritation Index (G.I.I.=0.08) indicates that the test product is very well tolerated.
Executive summary:

The study was conducted to verify the skin tolerance of the formulated test substance according to sensitization protocol described by Marzulli and Maibach. The study was performed in 49 healthy volunteers under occlusive patchway. The protocol corresponding to 3 periods: induction period corresponding to 9 consecutive occlusive epicutaneous applications for 48 or 72 hours during 3 weeks, rest period corresponding to 15 days with no application and challenge period corresponding to a 48 hour occlusive epicuteneous application. Irritation and sensitizing potential of the test substance were evaluated by macroscopic evaluation of the skin reactions. The irritation potential of the formulated product (5%) was evaluated after repeated applications during 3 weeks.

The test substance formulated at 5% in an emulsion exhibited a Global Irritation Index (G.I.I.=0.08) indicating that the test product is very well tolerated.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Two studies are available: one on guinea pig and one in human.

Guinea Pig Maximisation assay:

The aim of the study was to evaluate the possible allergenic activity of the test substance after intradermic injection and topical administration in guinea pigs. After induction (intradermic injection at 3.125% and topical application at 50 and 100%) of 11 Guinea Pigs of treated group with the test product and a 10-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product diluted at 50% and at 100%. The experimental protocol was established according the O.E.C.D. guideline n°406 dated July 17th, 1992 and the method B.6 of the council regulation N° 440/2008.

No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item. It was recorded a slight erythema in 9% (1/11) of the animals from the treated group, 24 and 48 hours after the challenge phase, on the treated area at 100%. No cutaneous intolerance reaction was recorded in animals from the negative control group. In conclusion, in view of these results, under these experimental conditions, the test substance needs not be classified, in accordance with the EU/UN GHS criteria.

Skin tolerance in human:

The study was conducted to verify the skin tolerance of the formulated test substance according to sensitization protocol described by Marzulli and Maibach. The study was performed in 49 healthy volunteers under occlusive patchway. The protocol corresponding to 3 periods: induction period corresponding to 9 consecutive occlusive epicutaneous applications for 48 or 72 hours during 3 weeks, rest period corresponding to 15 days with no application and challenge period corresponding to a 48 hour occlusive epicuteneous application. Irritation and sensitizing potential of the test substance were evaluated by macroscopic evaluation of the skin reactions. The irritation potential of the formulated product (5%) was evaluated after repeated applications during 3 weeks.

The test substance formulated at 5% in an emulsion exhibited a Global Irritation Index (G.I.I.=0.08) indicating that the test product is very well tolerated.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the classification criteria of UN/EU GHS, and given the absence of positive reactions in a GPMT and in a tolerance assay in human, C20/22 alkyl phosphate is not classified as a skin sensitizer.

No data are available for respiratory sensitisation; therefore no conclusion can be made on the classification of this end-point.