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EC number: 700-972-2 | CAS number: 93-83-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- From March 19, 1990 to May 2, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to Section 13 for details of the read-across justification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study available before the requirement for testing using the LLNA method was implemented.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino Bor:DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchem, Germany
- Average weight at study initiation: controls: 467 g; test group: 471 g
- Housing: 1 5 animals in macrolon Type IV cages
- Diet (e.g. ad libitum): G4 diet for guinea-pig, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Yes
- Acclimation period: 5 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 19-03-1990 To: 12-04-1990
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5%
- No. of animals per dose:
- Test group: 20
Controls: 10 - Details on study design:
- A 4 x 6 cm2 area was shaved on the shoulders of test animals. 2 to 3 h later, 6 intracutaneoius injections were made, simultaneously right and left: 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 of 0.5% test substance in maize oil, 0.1 cm3 of 0.5% test substance in FCA/water (1+1). Controls received 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 maize oil, 0.1 cm3 of FCA/maize oil (1+1).
One week later, a patch test was conducted: a 2 x 4 cm filter paper to which 60% test material in maize oil was applied to freshly shaved skin. The whole was covered with an adhesive bandage for 48 h. Controls received maize oil.
Two weeks later, the right and left flanks were shaved. After 2 - 3 h, a 2x2 cm filter paper with 20% test substance in maize oil was applied for 24 h to the left flank and covered with an adhesive bandage. The same treatment was made on the right flank of each animal with maize oil.
24 and 48 h after removal of the adhesive bandage, the reaction was scored. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- other: Not applicable
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the guinea-pig maximisation study, the test substance was considered to be non-sensitising.
- Executive summary:
A study was conducted to assess the sensitising potential of the read across substance, amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), in a guinea-pig maximisation test according to OECD Guideline 406. A 4 x 6 cm2 area was shaved on the shoulders of the test animals. Two to three hours later, 6 intracutaneous injections were made, simultaneously on the right and left: 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 of 0.5% test substance in maize oil, 0.1 cm3 of 0.5% test substance in FCA/water (1+1). Controls received 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 maize oil, 0.1 cm3 of FCA/maize oil (1+1). One week later, a patch test was conducted: a 2 x 4 cm filter paper to which 60% test substance in maize oil was applied to freshly shaved skin. The skin was covered with an adhesive bandage for 48 h. Controls received maize oil. Two weeks later, the right and left flanks were shaved. After 2 - 3 h, a 2 x 2 cm filter paper with 20% test substance in maize oil was applied for 24 h to the left flank and covered with an adhesive bandage. The same treatment was made on the right flank of each animal with maize oil. At 24 and 48 h after removal of the adhesive bandage, the reaction was scored. No effects were noted. Under the conditions of the guinea-pig maximisation study, the test substance was considered to be non-sensitising (Mürmann, 1990).
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