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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
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:
The study was conducted prior to adoption of the LLNA assay.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall Burton on Trent
- Females (if applicable) nulliparous and non-pregnant: [yes
- Microbiological status of animals, when known:
- Age at study initiation: <1 year old
- Weight at study initiation: 389-493g
- Housing: 5 per cage: aluminium with grid floor above peatmoss filled tray
- Diet (e.g. ad libitum): FD1 guineapig Diet, supplemted with Hay, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21C
- Humidity (%): 50%
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12/12 (0700-1900)
- IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
10% w/w
Day(s)/duration:
single dose
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
25% w/w
Day(s)/duration:
48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
25%
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 (twenty)
Details on study design:
RANGE FINDING TESTS:
Induction:
2 guinea pigs intradermal injections of 10%, 5%, 2% and 1% w/v in paraffin oil, assessed for irritation at 24, 48 and 72 hours
2 guinea pigs topical application of 25%,10%, 5% and 2% w/v in paraffin oil., assessed for irritation 24 and 48 hours after patch removal

Challenge: test material applied to shaved flanks at 25% and 10% w/v for 24hrs (occlusive dressing). Reactions assessed 24hours after patch removal.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two, one intrademal, one epicutaneous spaced 6 days apart
- Exposure period: 24 hours
- Test groups: one group of 20 animals
- Control group: one group of 20 animals
- Site: flank
- Frequency of applications: every six days
- Duration: 48 hours
- Concentrations: 10% w/v intradermal, 25% epicutaneous

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: Day 14
- Exposure period: 24 hours
- Test groups: one group of 20 animals (25% w/v)
- Control group: one group of 10 animals
- Site: left flank
- Concentrations: 25% w/v in paraffin oil
- Evaluation (hr after challenge): 24 and 48 hours after patch removal

OTHER:
Challenge controls:
vehicle and test material in non-induced animals
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:
0 % w/v
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% w/v
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
not given
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Dose rangefinding Induction:

No irritation was noted at sites injected with the test substance. 10% w/v was selected for the injection phase of induction.

No irritation was oted at sites treated topically with the test material. 25% w/v was selected for the topical appication phase of induction.

Main test-induction

slight to moderate irritation was noted in the test group and slight irritaiton noted in the control group.

Dose rangefinding -challenge

No irritation was noted at sites treated topically with the test material at 25% and 10% w/v in paraffin oil. 25% w/v was selected for the challenge dose.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
o-Chlorobenzotrichloride does not induce sensitisation in guinea-pig skin under the conditions of the performed study.