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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:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no details on the test substance; no details on the control group; as first induction step, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid guinea pig study is available peformed before the LLNA protocol was established
Species:
guinea pig
Strain:
other: Pirbright White Strain
Sex:
male/female
Details on test animals and environmental conditions:
The test was performed on 10 male and 10 female guinea pigs per
group weighing between 313 and 401 g ( 'vlo weeks old). The animals
were housed individually in Macrolon cages (type 3), assigned
to the different groups by means of random numbers generated
by the random number generator incorporated in the Hewlett-
Packard desk computer, identified with individual ear tags,
kept at a constant room temperature of 20 + 1 C, at a relative
humidity of 50 + 10% and on a 14 hours light cycle day. The
animals received ad libitum standard guinea pig pellets -
NAFAG No. 830, Gossau SG - and fresh water, supplemented with
fresh carrots.
The guinea pig is the animal of choice for sensitization studies
Route:
intradermal
Vehicle:
other: Adjuvant saline mixture = 50 % adjuvant complete Freund (Difco, Michigan), 50 % physiological saline
Concentration / amount:
0.1 ml
Day(s)/duration:
First and second induction week
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Induction: 10% in vaseline
Challenge: 30% in vaseline
Day(s)/duration:
1 d
No. of animals per dose:
20 animals (10 males/10 females) in the test group, no details concerning the control group
Details on study design:
The test was performed on 10 male and 10 female guinea pigs per
group weighing between 313 and 401 g ( 'vlo weeks old). The animals
were housed individually in Macrolon cages (type 3), assigned
to the different groups by means of random numbers generated
by the random number generator incorporated in the Hewlett-
Packard desk computer, identified with individual ear tags,
kept at a constant room temperature of 20 + 1 C, at a relative
humidity of 50 + 10% and on a 14 hours light cycle day. The
animals received ad libitum standard guinea pig pellets -
NAFAG No. 830, Gossau SG - and fresh water, supplemented with
fresh carrots.
The guinea pig is the animal of choice for sensitization studies.
Control group:
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Challenge controls:
After a rest period of 14 days the compound was
applied on filter paper patches ( 2 x 2 cm) to an untreated
flank skin of the animals for 24 hours epidermal occlusively.
Twenty four hours after removing the dressings the challenge reactions
were graded according to the Draize scoring scale (Appendix).
The application sites were chemically depilated before examination
(Veet , '^ 5 minutes)
Positive control substance(s):
not specified
Positive control results:
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
two male animals showed very slight erythema (grade 1); results of the control group were not given
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle and adjuvant
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Key result
Reading:
1st reading
Group:
positive control
Remarks on result:
other: no information on a positive control is available.
Interpretation of results:
GHS criteria not met
Conclusions:
Only two animals of the test group reacted after the challenge application of the test substance. The sensitizing potential of the test substance
can therefore be considered to be very low and the test substance is considered to be a non-sensitizer.
Executive summary:

The skin sensitizing potential fo the test susbtance was assessed in a Guinea pig mximization test (Ciba-Geigy, 1982). It was concluded that the test substance does not show a skin sensitizing effect in the Guinea Pig maximization test under the test conditions chosen.

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

The skin sensitizing potential fo the test susbtance was assessed in a Guinea pig mximization test (Ciba-Geigy, 1982). It was concluded that the test substance does not show a skin sensitizing effect in the Guinea Pig maximization test under the test conditions chosen.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the LLNA study conducted with the read-across substance, no classification is warranted EU CLP (EC 1272/2008) criteria.