Registration Dossier
Registration Dossier
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EC number: 236-751-8 | CAS number: 13473-90-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Chlorhydrol Ultrafine
- IUPAC Name:
- Chlorhydrol Ultrafine
- Reference substance name:
- aluminium chlorohydrate (ultra fine powder)
- IUPAC Name:
- aluminium chlorohydrate (ultra fine powder)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Chlorhydrol Ultrafine (aluminium chlorohydrate, ultra fine powder)
- Physical state: Solid (white powder)
- Lot/batch No.: Confidential information
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
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:
- water
- Remarks:
- distilled
- 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:
- water
- Remarks:
- distilled
- 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:
- Vehicle only patches on treated and control group animals
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No information on concurrent positive controls
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- 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 chemical
- 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 adverse 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 adverse skin reactions.
Any other information on results incl. tables
Bodyweight gains of guinea pigs in the test group between 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 Criteria used for interpretation of results: EU
- Conclusions:
- No evidence of skin sensitisation was seen in this study performed with the read-across substance aluminium chlorohydrate.
- 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 measured before and after the 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).
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