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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
Study period:
Study report dated 28 September 1976 (no additional details)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
no
GLP compliance:
no
Remarks:
prior to GLP
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
"This particular study (non-LLNA method test) was conducted in 1976, before the ECHA recommendation of conducting LLNA to fulfil the study requirement came into effect. Hence in order to avoid additional animal testing, this study has been used as key study for the dossier".
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
The animals, weighing between 400 to 450 grams, were housed individually in Macrolon cages, kept at a constant room temperature of 22 +/- 1° C, at a relative humidity of 55% +/- 5 % and on a 14 hours light cycle day. The animals received ad libitum standard guinea pig pellets (NAFAG, No. 830, Gossau SG) and water.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 % dilution in saline
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 % dilution in saline
No. of animals per dose:
20
Details on study design:
During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a
freshly prepared 0.1 % dilution in saline. One control group was treated with the vehicle alone (negative control). On the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
During the second and third week of the induction period the test materials were incorporated in a mixture (1:1) of the normal vehicle with 'complete Bacto Adjuvant.
Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % dilution of the test material in saline was administered into the skin of the left flank.
Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were
recorded. Before examination, the reaction sites were depilated chemically (Butoquick®, 5 minutes) The two largest perpendicular diameters (in mm)
and the increase in the skin-fold thickness (in mm) were measured, and by multiplication of these values "reaction volume" was obtained (in ul) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the "skin irritation threshold" for each animal. Any challenge reaction greater than this threshold value in the challenge period was graded as an allergic reaction and the animal termed "positive".
The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude (negative control).
Challenge controls:
One control group was treated with the vehicle alone (negative control) and a positive control group was treated with DNCB.
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene
Positive control results:
20/20 animals showed a positve response to DNCB (Dinitrochlorobenzene)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
irritation during induction was noted in 5 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: irritation during induction was noted in 5 animals.
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.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: criteria of assay
Conclusions:
According to the study report, the test material is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs.
Executive summary:

The optimization test, an intracutaneous sensitization procedure, was performed on groups of 10 male and 10 female guinea pigs. Induction doses were administered by intradermal injection with adjuvant incorporated 1:1 in vehilcle during weeks 2 and 3 of induction.

Fourteen days after the last induction injection, challenge was performed by injection.

Twenty-four hours after each injection during the first week of the induction period the reactions were recorded and skin thickness measured. Skin thickness was taken as representing the skin irritation "threshold" for each animal. Twenty-four hours the challenge injection the reactions were recorded.

Intradermal injection of the vehicle alone failed to induce a skin response before or after skin sensitization.

The incidence of positive reactors for the groups treated with DNCB was 20 of 20. The incidence of positive reactors for the groups treated with the test material was 5 of 20. According to the criteria of the Optimization test, the test material is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Migrated from Short description of key information:
20/20 guinea pigs showed no indication of sensitization in the Optimization test however, this study was conducted in 1976 and prior to GLP guidance and therefore based on structurale analogy of this substance with other epoxy substances, a precautionary/conservative classification as Skin sensitsation Cat 1B is recommended

Justification for selection of skin sensitisation endpoint:
20/20 guinea pigs showed no indication of sensitization in the Optimization test however, this study was conducted in 1976 and prior to GLP guidance and therefore based on structurale analogy of this substance with other epoxy substances, a precautionary/conservative classification as Skin
sensitsation Cat 1B is recommended

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

20/20 guinea pigs showed no indication of sensitization in the optimization test however, this study was conducted in 1976 and prior to GLP guidance and therefore based on structural analogy of this substance with other epoxy substances, a precautionary/conservative classification as Skin sensitsation Cat 1B is recommended.