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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989.02.10 -1989.07.25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is a standard Guinea pig maximation test performed under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
The Guinea pig maximization test
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study is a standard Guinea pig maximation test performed under GLP conditions.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Colourless liquid supplied by Norsolor (Groupe Orkem), Service Ecotoxicologie, B.P. 2, 60550 Verneuil en Halatte, France.
Vehicle used was paraffin oil, batch no. 6559 (Gifrer, 69151 Decines, France)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Animals were supplied by the Shamrock Bio Service breeding centre /78950 Gambais, France).
Animals were acclimatized for a minimum of 5 days prior to experiment, animals were identified by tatooing the ear.
Animals were kept in polycarbonate cages, equipped with polycarbonate drinking bottles, sifted and dusted sawdust were used as litter.
Temperature; 22 +/- 3 C
Relative humidity: 50 +/- 20 %
Light/dark cycle 12:12
Food ad libitum, certified pellet diet "Cobayes entretien reference 106"

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
1% of the substance in the vehicle, which is considered to be the maximum non-necrotizing administable dose
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
1% of the substance in the vehicle, which is considered to be the maximum non-necrotizing administable dose
No. of animals per dose:
5 males and 5 females (control group)
10 males and 10 females (test group)
Details on study design:
During a 10-day sensitization period. 2-phenoxyethyl acrylate was administered by intradermal injection at day 1, and by cutaneous application at day 9. After 15 days rest period another cutaneous application of the test substance was performed at day 26. The test substance was applied to the right flank and the vehicle to the left.
Positive control substance(s):
no

Results and discussion

Positive control results:
No positive control group included

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 % in paraffin oil
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Dryness of the skin was observed in all animals after 48 hours. No oedema was observed. Cutaneous reactions were slightly more marked in females than in males.
Remarks on result:
other: Erythema score 1 (7 male), Erythema score 2 (3 male)
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% i paraffin oil
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Dryness of the skin was observed in all animals after 48 hours. No oedema was observed. Cutaneous reactions were slightly more marked in females than in males.
Remarks on result:
other: Erythema score 1 (6 male), Erythema score 2 (4 male)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% paraffin oil
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Dryness of the skin was observed in all animals after 48 hours. No oedema was observed. Cutaneous reactions were slightly more marked in females than in males.
Remarks on result:
other: Erythema score 1 (4 female), Erythema score 2 (6 female)
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% paraffin oil
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Dryness of the skin was observed in all animals after 48 hours. No oedema was observed. Cutaneous reactions were slightly more marked in females than in males.
Remarks on result:
other: Erythema score 1 (4 female), Erythema score 2 (6 female)

Any other information on results incl. tables

No mortality occured during the experiment, and no clinical signs were observed. Bodyweight gain was slightly inferior to that of control animals.

On day 11, after removal of dressing, a slight necrosis in the control and a necrosis in the treated animals were observed.

After challenge application at day 26 a very slight (1) and well-defined (2)erythema was observed with following frequencies;

Males; after 24 hours erythem score 1 and 2 was observed in 7 and 3 out of 10, respectively.

Males; after 48 hours erythem score 1 and 2 was observed in 6 and 4 out of 10, respectively.

Females; after 24 hours erythem score 1 and 2 was observed in 4 and 6 out of 10, respectively.

Females; after 48 hours erythem score 1 and 2 was observed in 4 and 6 out of 10, respectively.

No signs of erythma were observed at the left flank of any of the animals.

Dryness of skin was observed in all animals after 48 hours.

No oedema was observed. Cutaneous reactions were slightly more marked in females than in males.

Due to an observation of "doubtful" macroscopic reactions, a histological examination was performed of the cutaneous samples of the right flank of the treated group.

The control group showed no morphlogical changes.

In the treated group a number of treatment related changes was observed;

A slight to moderate acanthosis (thickening of the skin) in all animals of both sexes.

A minimal to marked hyperkeratosis in all animals of both sexes.

A minimal to slight mononuclear or polynuclear cell infiltration in all animals of both sexes.

A slight to moderate vascular ectasia in all animals of both sexes.

Slight haemorrhages in 2 out of 10 females.

A moderate spongiosis in 1 out of 10 females.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Challenge exposure to 2-phenoxyethyl acrylate, showed to induce cutaneous reactions in guinea pigs, at a concentration of 1 % in paraffin oil, considered to be a result of a sensitization reaction. Based on these results, It is therefore concluded that 2-phenoxyethyl acrylate is a skin sensitizer.
Executive summary:

The sensitization potential of 2-phenoxyethyl acrylate was evaluated in the guinea-pig by intradermal injection and cutaneous application, according to the maximation method of Magnusson and Kligman (OECD 406) The study was performed under GLP conditions. Challenge exposure to 2-phenoxyethyl acrylate, showed to induce cutaneous reactions in guinea pigs, at a concentration of 1 % in paraffin oil, considered to be a result of a sensitization reaction.

Based on these results, 2-phenoxyethyl acrylate should be classified as a sensitizer according to the CLP regulation 1272/2008, as it meets the criteria; ≥ 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose. The test results corresponds to a classification as Skin. Sens. 1A.