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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
Study period:
13th September to 22nd October 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in a GLP compliant laboratory according to accepted regulatory guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Annex V (Maximisation test). 1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The skin sensitisation study was performed before adoption of the LLNA test in 2002.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Name of test material (as cited in study report):S-900
- Physical state: dark brown paste
- Lot/batch No.: 02869
- Storage condition of test material: room temperature In the dark, handled under non-actinic lighting only

- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 307 - 392g
- Housing: The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%): 30-70%
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark

IN-LIFE DATES: From: To: 13th September to 22nd October 1999

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: arachis oil and Freud's Complete Adjuvant (1:1 mixture with distilled water)
Concentration / amount:
5% v/v in arachis oil BP and 5% v/v in Freud's Complete Adjuvant (1:1 mixture with distilled water)
Day(s)/duration:
7 days after intradermal induction the same sites of the animals were further induced by epicutaneous exposure for two days.
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Day(s)/duration:
1 day
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
75%
Day(s)/duration:
1 day
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS:
For intradermal induction two concentrations (1% and 5%) in arachis oil were used indicating that 5% caused mild to moderate skin irritation.
For topical induction undiluted as well as in arachis oil diluted substance was used indicating that undiluted substance caused mild irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 exposures, first intradermal induction followed after 7 days by topical induction with undiluted substance for 2 days.
- Exposure period: intradermal plus 2 days topical induction of the same animals
- Test groups: 1 test group of 10 animals
- Control group: 1 control group of 5 animals
- Site: shoulder region
- Frequency of applications:
- Duration:
- Concentrations:

B. CHALLENGE EXPOSURE
- No. of exposures: 1 exposure
- Day(s) of challenge:
- Exposure period: 1 day
- Test groups:
- Control group:
- Site: flank region
- Concentrations: undiluted to the right side, 75% in arachis oil to the left side
- Evaluation (hr after challenge): 24 h and 48 h after challange

OTHER:
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Group:
positive control
Dose level:
25%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation during induction:
Discrete or patchy to moderate and confluent erythema was
noted at the intradermal induction sites of all test group
animals at the 24 and 48 hour observations.

Brown coloured residual test material prevented accurate
evaluation of erythema after topical induction.

Evidence of sensitisation of each challenge concentration:
Number of animals showing evidence of sensitisation at each
challenge concentration: None

Other observations:
Bodyweight gains of animals in the test group, between Day 0
and Day 24, were comparable to those in the control group.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material, S-900, produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No symbol and risk phrase are required.