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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report which meets basic scientific principles, acceptable with restrictions (second challenge not performed)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Maurer optimisation test
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 400-450 g
- Housing: single
- Diet (e.g. ad libitum): standard guinea pig pellets - NAFAG, Gossau SG
- Water (e.g. ad libitum): tap water
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 10/14
Route:
intradermal
Vehicle:
other: polyethylene glycol + saline (70 : 30 parts)
Concentration / amount:
0.1 %
Route:
intradermal
Vehicle:
other: polyethylene glycol + saline (70 : 30 parts)
Concentration / amount:
0.1 %
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 8
- Exposure period: 3 weeks
- Test groups: During the 1st week volumes of 0.1 ml of the test substance without adjuvant were injected intradermally on Monday at two sites (flank and back), and on Wednesday and Friday at each one site on the back. Twenty-one hours after administration, the animals were chemically depilated with Butoquick and three hours later the skin reaction was assessed under artificial lighting. The two largest diameters of the erythematous reaction in vertical alignment were measured (mm) and the skin-fold thickness was determined with a skin-fold gauge (mm). The individual "reaction volume" (µl) was calculated from these values for each reaction from each animal. During the second and third week of induction the substance was mixed with adjuvant in a 1:1 ratio. A total of 6 sensitizing doses of 0.1 ml were injected intracutaneously into the skin of the neck on Monday, Wednesday and Friday. The reactions were not evaluated on these occasions.
- Control group: treated in the same manner with the control vehicle alone (20 guinea pigs)
- Concentrations: 0.1 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the last sensitizing treatment with the adjuvant mixture.
- Test groups: 0.1 ml of the same substance formulation, as employed during the first testing week, was injected intradermally on the previously untreated flank. Twenty-four hours later the reaction site was evaluated in the same manner as during the first testing week.
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24

Skin sensitization was defined to occur of the challenge reaction whenever the reaction volume exceeded the mean value + one SD of the 4 pre-sensitization responses.
Challenge controls:
A group of 20 guinea pigs treated in the same manner with the control vehicle alone served as negative and another group treated with Dinitrochlorobenzene (DNCB) as positive controls
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene (DNCB)
Statistics:
The number of positive animals in each group was counted with significant differences between treated and control groups assessed by the Fisher test.
Positive control results:
All guinea pigs treated with Dinitrochlorobenzene (DNCB) exhibited positive reactions.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 %
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 %. No with. + reactions: 20.0. Total no. in groups: 20.0.

Rate of positive reactions: Test item, polyethylene glycol + saline and DNCB treated groups and p = level of significant difference with control group:

Compound

Rate of positive reactors

P

polyethylene glycol + saline

1/20

>0.01

DNCB

20/20

<0.001

test item

4/20

>0.01
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance is considered to possess no skin-sensitizing (contact allergenic) potential in albino-guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test substance was tested using Maurer Optimisation Test with 8 induction exposures (intradermally, 0.1 %) and one challenge exposure two weeks later with the same concentration (CIBA-GEIGY 1976). No second challenge with non-irritating concentration was performed. The test resulted in 4 positive reactors in the test group and 1 positive reactor in the control group. All animals showed positive reactions in the positive control group.

In a human patch test (CIBA-GEIGY 1963) performed with 58 volunteers (15 males and 43 females, 16-73 years of age), 0.5% of the test material in dimethyl phthalate causes little irritation. Only one of 58 subjects became sensitive to the test material during the test. This subject had reported an earlier dermatitis following use of cuticura. Therefore the overall results can be considered as negative. Based on the results, the test substance possess no skin-sensitizing (contact allergenic) potential.


Migrated from Short description of key information:
The substance caused no skin sensitization in the Maurer Optimization test in guinea pigs (Ciba-Geigy 1976).

Justification for selection of skin sensitisation endpoint:
Well documented study report

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No experimental data is available regarding respiratory sensitization. In the absence of skin sensitization, respiratory sensitization is not expected.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.