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Toxicological information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study was already available before registration

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Physical state: grey/green powder
- Analytical purity: 96%
- Lot/batch No.: 326-104
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Limited, Bicester, Oxfordshire, UK.
- Age at study initiation: seven to eight weeks.
- Weight at study initiation: 339 - 469 g.
- Housing: 5 animals per cage.
- Diet: Guinea pig F.D.1 (Special Diet Services, Essex, UK), ad libitum and regular supplement of autoclaved hay.
- Water: tap water ad libitum.
- Acclimation period: 13 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23 °C.
- Humidity (%): 40 - 70 %.
- Air changes (per hr): 15.
- Photoperiod (hrs dark / hrs light): 12 h / 12 h.

:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.2 mL FCA
0.2 mL of 0.5% TS in destilled water
0.2 mL of 0.5% TS in FCA
Day(s)/duration:
day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.6 mL of 30% TS in distilled water
Day(s)/duration:
application on day 8, occlusive dressing for 48 hours
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.03 mL of 30% TS in distilled water and 0.03 mL of 5% TS in distilled water
Day(s)/duration:
application on day 22, occlusive dressing for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
destilled water (0%TS)
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
destilled water (0% TS)
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
destilled water (0% TS)
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
destilled water (0% TS)
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30% TS in water
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: slight erythema
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30% TS in water
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: eschar formation
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30% TS in water
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: 4 animals with slight erythema, 1 with moderate erythema and 5 with eschar formation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30% TS in water
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: 1 animal with slight erythema and 4 animals with eschar formation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% TS in water
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% TS in water
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5% TS in water
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: 2 animals with slight erythema and 1 animal with eschar formation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5% TS in water
No. with + reactions:
0
Total no. in group:
20

Any other information on results incl. tables

Signs of irritation during induction: Intradermal administration in the range 5 % to 30 % w/v in distilled water caused moderate erythema and black and/or green discolouration 24 and 48 hours after administration.

Evidence of sensitisation of each challenge concentration: A significant dermal response (slight erythema or a more marked reaction) was apparent in 12 test and three control animals challenged with 30 % test substance in distilled water and in three test and no control animals challenged with the 5 % formulation. No dermal response was observed in any test or control animals following challenge with distilled water alone.

The incidence of significant responses in the test animals was markedly greater than in the controls and was in excess of the EC limit value (30 %) for classifying the test material as a dermal sensitiser. It is therefore, concluded that, under the conditions of this study, repeated administration caused delayed contact hypersensitivity in the guinea-pig.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Classification: May cause sensitization by skin contact