Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
in vivo
Type of information:
other: read across form similar substance (analogue structure or surrogate)
Adequacy of study:
key study
Study period:
From April 01st to May 08th, 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted July 17, 1992
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Already available study

Test material

Constituent 1
Reference substance name:
Similar Substance 03, AR336
IUPAC Name:
Similar Substance 03, AR336

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, D-33178 Borchen. SPF breeding colony.
- Weight at study initiation: mean 388 g.
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals.
- Diet: ssniff® Ms-H (V2233), ad libitum.
- Water: tap water in plastic bottles, ad libitum.
- Acclimation period: at least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Relative humidit: 50 ± 20 %
- Photoperiod: 12 hours daily dark / 12 hrs light.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20.0 % in deionized water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
20 % alpha-hexyl cinnamic aldehyde in polyethylene glycol 400
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Irritations during the sensitization phase

Discrete or patchy erythema occurred sporadically in the treatment group after the first induction treatment. Discrete or patchy up to moderate and confluent erythema were observed in the treatment group during the sensitization phase after the second and third administration. The animals of the control group showed no signs of irritation during the sensitization phase.

Based on these results, a 20 % preparation of test item in deionized water was selected for the challenge treatment.

Dermal challenge treatment

No signs of irritation were observed in the control and the treatment group 24 and 48 hours after removal of the occlusive bandage.

Body weight gains and clinical signs

The body weight gains of the animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study. 0

RANGE FINDING TESTS

No signs of irritation occurred after administration of the different test concentrations.

Based on these results, 100 % test item was selected for the sensitization treatments.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
Not skin sensitising
Executive summary:

Testing for the sensitizing properties of test item was performed in female guinea pigs according to the method of Burhelr, according to the OECD guideline 406.

Dermal induction was performed using 100 % test item moistened with deionized water. The control group was exposed to deionized water only. Challenge treatment was carried out with 20 % test item in deionized water. The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the Buehler test.

No signs of irritation were observed in the control and the treatment group 24 and 48 hours after removal of the occlusive bandage. Based on the results of the study, the substance showed no evidence for sensitizing properties.

Conclusion

Not skin sensitising