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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation: The skin sensitisation potential was investigated by performing a guinea pig maximisation test equivalent with OECD 406 (1981) guideline. A concentration of 1% was used for the intradermal induction, 50% for the epidermal induction and 25% for the four challenges. As only one of the ten test group animals showed sensitisation effects 48 hours after challenge (total of four challenges), the substance was not considered to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 April, 1980 - 18 February, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability 2 is assigned because the study is conducted equivalent to OECD TG 406, but non-GLP with minor defficiencies on documentation which did not influence the outcome of the test.
Justification for type of information:
This study was available before update of the REACH Regulation requesting in vitro sensitisation data as default requirement (October 2016)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
No information on environmental conditions and housing of the animals were provided this did not influence the result of this study.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA is not considered necessary because a valid GPMT test is available.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Environmental Safety Laboratory
- Age at Acclimatization Start: No data
- Weight at Acclimatization Start: males: 304 - 350g; females: 320 - 334 g
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
No data
Route:
intradermal and epicutaneous
Vehicle:
other: 0.01% Dodecylbenzene sulphonate/saline for the intradermal induction, ethanol for the epicutaneous induction and challenge.
Concentration / amount:
- 1% for the intradermal induction
- 50% for the epidermal induction
- 25% for the challenge
Route:
epicutaneous, occlusive
Vehicle:
other: 0.01% Dodecylbenzene sulphonate/saline for the intradermal induction, ethanol for the epicutaneous induction and challenge.
Concentration / amount:
- 1% for the intradermal induction
- 50% for the epidermal induction
- 25% for the challenge
No. of animals per dose:
Test animals: 10 (6 males, 4 females)
Treated control animals: 4 males
Untreated control animals: 4 females
Details on study design:
RANGE FINDING TESTS
- Intradermal injections:
Four guinea pigs of the same sex and weighing approximately 320 g are each injected intradermally on the clipped flanks with 0.1 mL aliquots of a range of concentrations of test substance in a suitable solvent. Twenty-four hours later the reactions are examined for size in mm (length and breadth) and for erythema and oedema. A concentration which produces a definite irritation reaction is selected as the intradermal induction concentration.
- Epidermal application: No data.

MAIN STUDY
EXPERIMENTAL DESIGN:
Animals were treated by intradermal injections in the shoulder region to induce sensitization and 7 days later the sensitization is boosted by an occluded patch placed over the injection site. 14 days later the animals were challenged on one flank by occluded patch. Seven days after this a further confirmatory challenge was given on the opposite flank using the same method. Further challenges may be required at weekly intervals to resolve uncertainties in the first two challenges.

CHALLENGE:
Thirteen to 14 days after application of the induction patch the animals were challenged on the clipped and shaved flank by occluded patch. For each animal, an 8 mm diameter filter paper patch in an 11 mm aluminium patch test cup was saturated with test substance at the selected challenge concentration and the patch applied to the shaved flank. The patch was held in place for 24 hours by adhesive plaster wound around the trunk. The treatment sites were examined for evidence of sensitization 24 and 48 hours after removal of the patches.
One week after the first challenge a second challenge was made on the opposite flank exaectly as for the first challenge. Further challenges and cross challenges may be made on alternate flanks at weekly or greater intervals as required.

Controls:
Treated control group:
At the same time as the test guinea pigs are selected, 4 guinea pigs of the same sex are selected as treated controls for the first challenge. They are given a mock induction tretament at the same time and in the same way as for the test animals except that test substance is omitted from the injection and application preparations. At first challenge they are treated in exactly the same way as the test animals.

Untreated control group:
At every challenge in the test 4 previously untreated guinea pigs, weighing approximately the same as the test guinea pigs at the challenge, are treated in exactly the same way as the test animals.


Positive control substance(s):
no
Reading:
other: challenge 1
Hours after challenge:
24
Group:
other: treated control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 24.0. Group: other: treated control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 1
Hours after challenge:
24
Group:
other: untreated control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 24.0. Group: other: untreated control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 1
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
other: challenge 1
Hours after challenge:
48
Group:
other: treated control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 48.0. Group: other: treated control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 1
Hours after challenge:
48
Group:
other: untreated control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 48.0. Group: other: untreated control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 1
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
other: challenge 2
Hours after challenge:
24
Group:
other: untreated control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 2. . Hours after challenge: 24.0. Group: other: untreated control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 2
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 2
Hours after challenge:
48
Group:
other: untreated control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 2. . Hours after challenge: 48.0. Group: other: untreated control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 2
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 2. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 3
Hours after challenge:
24
Group:
other: untreated control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 3. . Hours after challenge: 24.0. Group: other: untreated control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 3
Hours after challenge:
24
Group:
test chemical
Dose level:
10%+25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 3. . Hours after challenge: 24.0. Group: test group. Dose level: 10%+25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 3
Hours after challenge:
48
Group:
other: untreated control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 3. . Hours after challenge: 48.0. Group: other: untreated control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 3
Hours after challenge:
48
Group:
test chemical
Dose level:
10%+25%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 3. . Hours after challenge: 48.0. Group: test group. Dose level: 10%+25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
other: challenge 4
Hours after challenge:
24
Group:
other: untreated control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 4. . Hours after challenge: 24.0. Group: other: untreated control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 4
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 4. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 4
Hours after challenge:
48
Group:
other: untreated control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 4. . Hours after challenge: 48.0. Group: other: untreated control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 4
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 4. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.

- In the pre-liminary test, erythema (faint pink and pale pink) and oedema was observed at intradermal induction with 1% test substance in 0.01% dodecylbenzene sulphonate/saline in all 4 animals. Therefore 1% for the intradermal induction was used.

At 24 hours after the topical induction of 50% test substance in ethanol 2 of the 4 animals showed barely perceptible erythema erythema, the other 2 animals showed no effects. The 50% concentration was considered suitable for application induction.

For the challenge 25% was determined to be the highest non-irritant concentration.

- The body weight gain of the animals was normal.

- In the challenge readings of the main test, the skin reaction barely perceptible erythema (also observed in the treated and untreated controls) were not considered as skin sensitising effects.

Interpretation of results:
other: not sensitising
Remarks:
CLP criteria 1272/2008 and its amendments
Conclusions:
In a guinea pig maximisation test performed equivalent with OECD 406 (1981) guideline, the substance is not considered a skin sensitiser.
Executive summary:

The skin sentisation potential of the substance was investigated by performing a guinea pig maximisation test equivalent with OECD 406 (1981) guideline. A concentration of 1% was used for the intradermal induction, 50% for the epidermal induction and 25% for the four challenges. As only one of the ten test group animals showed sensitisation effects 48 hours after challenge (total of four challenges), the substance was not considered to be a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Respiratory sensitisation can be assessed using human data such as indicated in R7.3.5.2 of the ECHA guidance (2014) that indicate respiratory reactions e.g. from consumer experience or occupational exposure. In the absence of such data, the respiratory sensitisation was assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-2, 2014). This substance is not expected to be of concern for respiratory sensitisation because it is not a skin sensitiser.

Justification for classification or non-classification

In view of the absence of skin sensitisation the substance need not be classified and labelled for skin and not for respiratory sensitisation according to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.