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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:
June 23 - August 8, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Optimization test without GLP. Neither OECD guidelines nor GLP (for non-pharmaceuticals) were were in place when the study was performed. The study was perfromed in a GLP lab (for pharmaceuticals) and is well documented. The test system is validated.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Maurer test protocol for optimization test
Deviations:
no
GLP compliance:
no
Remarks:
study performed before GLP were in place
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
The study have been performed before the REACh legislation enters into force.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Substance type: organic
- Physical state: liquid
- Storage condition of test material: In refrigerator (2-8°C) in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd. Sisseln, Switzerland
- Weight at study initiation: 370 - 460 grams
- Housing: individual caging in type 3 Macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 deg C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours light per day

IN-LIFE DATES: From: To: June 23, 1980 - August 8, 1980

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
0.1%
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
0.1%
No. of animals per dose:
10 males and 10 females
Details on study design:
RANGE FINDING TESTS: not reported

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 intradermal injections in total
- Exposure period: 22 days
- Test groups: 10 animals
- Control group: 10 animals (vehicle)
- Site: right flank (shaven) and on the back for the 1st injection, and on the followwing days a single injection into the back
- Frequency of applications: 3 injections per week, 2 days intervals
- Duration: 22 days induction and 14 days rest period
- Concentrations: 1 (0.1%)
- Adjuvant: Injections during the 2nd and 3rd week were done with a mixture 1:1 of vehicle and complete Freud adjuvant (Bacto).

B. CHALLENGE EXPOSURE
- No. of exposures: 1 intradermal challenge injection and 1 epicutaneous challenge patch
- Day(s) of challenge: 10 days interval between challenge injection and challenge patch
- Exposure period: challenge patch: 24 hours
- Test groups: 1
- Control group: 1
- Site: left flank
- Concentrations: 1 (0.1%)
- Evaluation (hr after challenge): 24 hours
Challenge controls:
vehicle (propylene glycol) plus 0.1% test material
Positive control substance(s):
not required
Remarks:
Tests with positive controls have been run periodcally in separate experiments.

Results and discussion

Positive control results:
not available

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: none reported.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1% in propylene glycol
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% in propylene glycol. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: none reported.
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1% in propylene glycol
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% in propylene glycol. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: none reported.

Any other information on results incl. tables

Incidence of positive animals per group after intradermal challenge Injection

Negative control group : positive reaction in 2/10 males and 2/10 females => 4/20

Testing group : positive reaction in 5/10 males, and 3/10 females => 8/20

Incidence of positive animals per group after occlusive epicutaneous application

Negative control group : 0/20

Testing group : 20/20

Challenge reactions after occlusive epicutaneous administration of the test material

Animal No. male :                     2361        2362        2363        2364        2365        2366        2367        2368        2369      2370

Erythema score (Draize Score)

24 hours after removal of the       2              2              2              2               2            1             2              2              2              2

dressing.

Animal No. female : 2371 2372 2373 2374 2375 2376 2377 2378 2379 2380

Erythema score (Draize Score)

24 hours after removal of the 2 2 2 1 2 2 2 2 2 2

dressing.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after epidermal challenge application of the test material.
The test material is therefore considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs.
Executive summary:

Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after epidermal challenge application of the test material.

The test material is therefore considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs.