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Registration Dossier
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EC number: 944-296-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 6 to April 4, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Source study has reliability 1. Details on the read across are attached in section 13.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test was already avaiable, which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- Similar Substance 02
- IUPAC Name:
- Similar Substance 02
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH.
- Weight at study initiation: 263 - 350 g.
- Housing: in groups of 5 per Type IV Makrolon cage.
- Diet: Kliba rabbit and guinea pig maintenance diet (341.4 mm); ad libitum.
- Water: tap water (drinking water with about 2g of ascorbic acid in 10 I water twice a week); ad libitum.
- Acclimation period: not less than 6 days before the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod (hrs dark/hrs light): 12/12.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's adjuvant, distilled water
- Concentration / amount:
- intradermal: 5 %
epicutaneous: 50 %
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freund's adjuvant, distilled water
- Concentration / amount:
- 20 %
- No. of animals per dose:
- Test group: 20
Each control group: 10 - Details on study design:
- RANGE FINDING TESTS:
- Administration volume: filter paper strips of 2 × 2 cm edge length were allowed to take effect in the region of the flank under occlusive conditions.
- Exposure time: the test substance was administered for 2 × 24 hours within a period of 96 hours in order to detect unspecific phenomena which are not based on a sensitization reaction but which might displace the irritation threshold.
- Site of administration: region of the flank, in each case in the same place.
- Number of animals: 4 for each test concentration.
- Readings: approximately 24 and 48 hours after the start of administration.
MAIN STUDYA. INDUCTION EXPOSURE: INTRADERMAL INDUCTION
- No. of exposures: 6 intradermal injections, two at a time, for each animal.
- Exposure period: single application.
- Two control groups: the animals received the same injections, but without the test substance and only with the agent which was used for preparing the suspension.
- Site: shoulder region
- Concentrations: 5 %
B. INDUCTION EXPOSURE: EPICUTANEOUS INDUCTION
- Time schedule: one week after intradermal induction
- Exposure: liquid immersed filter paper strips of 2 × 4 cm edge length under occlusive conditions.
- No. of exposures: 1
- Exposure period: 48 h
- Site: shoulder region, in the same area as previously with the intradermal application.
- Concentrations: 50%
C. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: the first dose approximately 14 days after the epicutaneous induction, the second dose one week later.
1st challenge: test group and control group 1 (control group 2 untreated);
2nd challenge: test group and both control groups.
- Exposure: liquid immersed filter paper strips of 2 × 2 cm length under occlusive conditions.
- Exposure period: 24 h
- Site: intact clipped region of the flank.
- Concentrations: 20 %
- Evaluation: approximately 24, 48, 72 hours after the start of administration.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: negative control group 2
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: negative control group 2
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
Any other information on results incl. tables
1/10 animals of control group 1 died 4 days after intradermal induction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No sensitising potential.
- Executive summary:
Method:
The substance was tested for sensitising effects on the skin of the guinea pig in a maximisation test, according to OECD guideline 406. Induction was done by intradermal route and by epicutaneous route using concentrations of 5% and 50%, respectively. Epidermal challenge was done by applying test substance at a concentration of 20%.
Results:
After the challenge application, no cutaneous reactions were observed in animals of both control and test groups at the 24-hour and 48-hour readings.
Therefore, test substance did not show any sensitising potential.
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