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Diss Factsheets

Administrative data

Description of key information

No skin sensitizer in a GPMT (OECD 406, GLP)

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:
From March 9, 1983 to April 2, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study (GPMT) was conducted prior to the implementation of the LLNA method
Specific details on test material used for the study:
A 200ml sample of the test substance was received from the sponsor on December 17, 1982. It was a clear colourless liquid, designated: Sinodor X-09648, No. 211234, date 13.12.82.
Species:
guinea pig
Strain:
not specified
Remarks:
Mouse, CBA/J strain, inbred, SPF-Quality.
Sex:
male
Details on test animals and environmental conditions:
Main test is conducted with 15 young male SPF bred albino guinea pigs (body weight 200-400g) obtained from the central intitute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands.
The experiment is preceded by an acclimatization period of at least two days to accustom the animals to the environmental conditions prevailing in our laboratory.
The guinea pigs are kept under conventional conditions and individually housed in suspended stainless steel cages, fitted with wire mesh floors and fronts. The temperature in the animal room is kept at 21 +/- 1 °C, the relative humidity at 40% at least and a 12 h light/dark cycle is maintained.
The guinea pigs are fed pelleted stock diet from Hope Farms (Woerden, The Netherlands). The diet as well as tap water are provided ad libitum throughout the experiment.
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
10%
Day(s)/duration:
24h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
intradermal
Vehicle:
other: Mixture of FCA and Propylene Glycol (1:1)
Concentration / amount:
10%
Day(s)/duration:
24h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
intradermal
Vehicle:
other: FCA
Concentration / amount:
0%
Day(s)/duration:
24h
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
25%
Day(s)/duration:
48h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
10%
Day(s)/duration:
24h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Control group: 5 animals
Test group: 10 animals
Details on study design:
The test was divided into two stages:
a) induction treatment by intradermal injection and topical application
b) challenge treatment by topical application

Induction is effected in a two-stage operation consisting of, firstly, three pairs of intradermal injections made simultaneously and, secondly, one week later, a closed patch exposure performed over the injection sites. For this purpose an area of c. 24 cm2 of dorsal skin in the shoulder region is clipped free of hair with electric clippers.

The induction by intradermal injection was performed in two rows of each three injection sites in the shoulder region as follows:
Test animals:
- two injections (0.1 ml) of Freund's Complete Adjuvant (FCA)
- two injections (0.1 ml) of a 10% dilution (w/v) of Sinodor in propylene glycol (PG)
- two injections (0.1 ml) of a 10% dilution (w/v) of Sinodor in FCA and PG (1:1)
Control animals:
- two injections (0.1 ml) of Freund's Complete Adjuvant (FCA)
- two injections (0.1 ml) of propylene glycol (PG)
- two injections (0.1 ml) of FCA and PG (1:1)

Skin readings are made 24h after the treatment.

One week after the intradermal injections, the induction by topical application was made in the same shoulder region. The test animals were treated with a 25% dilution (w/w) of Sinodor in vaseline. The controls were similarly treated with vaseline alone.
The test animals are treated as follows: a 2x4cm patch of Whatman No 3 MM filter paper is loaded with the appropriate mixture of the test substance and carrier. The patch is placed over the sites of the intradermal injections and covered with a piece of PVC foil and a piece of Leukopor hypo-allergic paper bandage. This, in turn, is secured with a 7.5cm wide Tensoplast bandage. The dressing is left in place for 48h. The control animals are similarly treated with patches with carrier only. Skin readings are made after removal of the patches.

The challenge was carried out two weeks after the topical induction in both test and control animals. The right flank of all animals was topically treated with a 10% dilution (w/w) of Sinodor in vaseline.
An area of 5x5 cm on the left flank of each animal is clipped free of hair and closely shaved. Subsequently a Silverpatch is loaded with the appropriate mixture of the test substance and carrier and place in the centre of the shaved area. The patch is covered with Leukopor bandage which is held in place by Tensoplast. The control animals are also treated with the test substance. The patches are left in place for 24 h. Skin readings are made immediately after removal of the patches and 24 and 48h thereafter.
The response are given a score according to Draize et al. (1944).
Challenge controls:
The challenge was carried out two weeks after the topical induction in both test and control animals. The right flank of all animals was topically treated with a 10% (w/w) of Sinodor in Vaseline. The patches are left in place for 24h. Skin readings are made immediately after removal of the patches and 24 and 48h thereafter.
One of the five control animals reacted positively immediately after removal of the dressing.
After 24 and 48 h, none of the control animals showed erythema reactions.
Positive control substance(s):
no
Positive control results:
No postive controls done.
Reading:
1st reading
Hours after challenge:
0
Group:
negative control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
Very slight erythema immediately after removal of the dressing
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
10%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Very slight erythema immediately after removal of the dressing
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation

Like 24 hours after removal of the challenge dressing, none of the test and control animals showed erythema reactions after 48 hours too.

Interpretation of results:
GHS criteria not met
Conclusions:
Since none of the test animals showed erythema reactions in the challenge test at the 24 hours reading, it is concluded that the test substance did not induce delayed contact hypersensitivity in any of the guinea pigs under the conditions of the test.
Executive summary:

The test substance Sinodor was examined for possible senitization potential by a maximisation test in guinea pigs.

From the reaction to the challenge treatment with a 10% dilution of the test substance in vaseline, it was concluded that the test substance did not induce delayed contact hypersensitivity in guinea pigs under the conditions of the test.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Skin sensitisation GPMT test:

The test substance Sinodor was examined for possible senitization potential by a maximisation test in guinea pigs.

From the reaction to the challenge treatment with a 10% dilution of the test substance in vaseline, it was concluded that the test substance did not induce delayed contact hypersensitivity in guinea pigs under the conditions of the test.

Justification for classification or non-classification

Based on the data available and key results described in this summary, the substance has shown no skin sensitizing potential and should therefore not be classified for skin sensitisation according to the (EC) No 1272/2008 Regulation (CLP).