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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
3 January 1986 - 8 February 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD guideline 406 and under GLP conditions
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Scale for classification of sensitizing potential is used (see materials&methods)
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chlorhydrol Ultrafine
- Physical state: Solid (white powder)
- Lot/batch No.: Confidential information
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 7-11 weeks
- Weight at study initiation: 334-411 g
- Housing: In groups of up to 4 animals
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum, tap water
- Acclimation period: Min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 45-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: distilled water
Concentration / amount:
Intradermal induction: 0.1% w/w
Topical induction: 50% w/w
Topical challenge: 50% w/w
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
Intradermal induction: 0.1% w/w
Topical induction: 50% w/w
Topical challenge: 50% w/w
No. of animals per dose:
Treatment group: 20
Control group: 10
Details on study design:
RANGE FINDING TESTS:
Dose levels for each of the three stages of the main study were determined. Groups of two or more guinea pigs were used and up to two dose levels were tested on each group of animals.
Intradermal injection: Dilutions of test material in distilled water were tested to determine the highest level, up to 5% (w/v), that could be well tolerated both locally and systemically.
Topical application: Dilutions of the test material in distilled water were tested to determine the highest level which did not produce excessive inflammation and irritation in animals injected with FCA at least seven days previously.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 48 hours (epicutaneous)
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: Shoulder region (40x60 mm)
- Frequency of applications: Once
- Concentrations:

Treatment group:
- Intradermal (row of 3x0.1 ml injections on each side of the midline):
1. FCA plus distilled water in the ratio 1:1
2. A 0.1% (w/v) dilution of test material in distilled water
3. A 0.1% (w/v) dilution of test material in a 1:1 prepartion of FCA plus distilled water
- Epicutaneous:
Topical occlusive application of 0.2-0.3 ml test material (50% w/w in distilled water) on filter paper

Control group:
- Intradermal (row of 3x0.1 ml injections on each side of the midline):
1. FCA plus distilled water in the ratio 1:1
2. Distilled water
3. FCA plus distilled water in the ratio 1:1
- Epicutaneous:
Topical occlusive application of 0.2-0.3 ml distilled water on filter paper

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period: 24 hours
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: 50-70 x 50 mm area on both flanks
- Concentrations: 50% in distilled water
- Evaluation (hr after challenge): 24 and 48 hours after removal of dressing. Four-point scale was used to record erythematous reactions:
0 - no reaction
1 - scattered mild redness
2 - moderate and diffuse redness
3 - intense redness and swelling

Number of positive responses was recorded, the sensitization response was calculated (% positive reactions) and this was compared with the following scale:
0% - non-sensitizer
1-28% - mild sensitizer
29-65% - moderate sensitizer
66-100% - strong sensitizer

OTHER:
Body weights measured at start and end of study.
Challenge controls:
Not relevant
Positive control substance(s):
no

Study design: in vivo (LLNA)

Vehicle:
other: Not relevant
Concentration:
Not relevant
No. of animals per dose:
Not relevant
Details on study design:
Not relevant
Statistics:
Not relevant

Results and discussion

Positive control results:
Not relevant

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse skin reactions
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse skin reactions
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse skin reactions.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse skin reactions
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% Chlorhydrol Ultrafine
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No advese skin reactions
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No advese skin reactions.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not relevant
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not relevant

Any other information on results incl. tables

Bodyweight gains of guinea pigs in the test group betwee day 0 and day 24 were comparable to those in the control group over the same period.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this Guinea Pig Maximisation Test (OECD 406), Chlorhydrol Ultrafine did not induce any adverse skin reactions in the test group (sensitization rate: 0%). Therefore, the substance does not need to be classified as a sensitizer based on the classification criteria outlined in Annex I of CLP (1272/2008).
Executive summary:

The present sudy was used to determine the sensitizing potential of Chlorhydrol Ultrafine in guinea pigs (Guinea Pig Maximisation Test, OECD 406). 20 animals were exposed once intradermally (0.1%) and 2 times epicutaneously (50%) to the test article. 10 control animals were only exposed once epicutaneously (50%) during challenge. Positive skin reactions were evaluated according to a grading scale, and were used to calculate the sensitization rate. Body weights were measure before and after study.

No positive skin were observed, the sensitization rate was established to be 0%. Body weight gain was comparable between the test and control group.

As the sensitization rate of 0% does not exceed the threshold value of 30%, the substance does not need to be classified as a sensitizer based on the classification criteria outlined in Annex I of CLP (1272/2008).