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EC number: 203-328-4 | CAS number: 105-76-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.06.1987 - 24.06.1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to OECD guideline 406 but GLP standards were not applied. However, study was well conducted and documented. However, observation time did not go beyond 48 hours for reversibility.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- A GLP statement is not included. However, it is stated in the report that raw data, study plan, report, and samples are stored in the archive of the Hüls AG (now Evonik).
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo skin sensitisation study was carried out before the entry into force of the amendments to Annex VII
Test material
- Reference substance name:
- Dibutyl maleate
- EC Number:
- 203-328-4
- EC Name:
- Dibutyl maleate
- Cas Number:
- 105-76-0
- Molecular formula:
- C12H20O4
- IUPAC Name:
- dibutyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Dibutylmaleinat, Maleinsäure-di-n-butylester
- Substance type: active substance
- Physical state: clear liquid
- Analytical purity: 96.5%
- Day of production: 18 March 1987
- Lot/batch No.: 930
- Expiration date of the lot/batch: not reported
Constituent 1
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: Commercial supplier
- Weight at study initiation: 340.4-346.3 g
- Housing: 1 - 5 animals in Makrolon type IV cages
- Diet (e.g. ad libitum): G4 diet for guinea pigs ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 60% +/- 5 %
- Air changes (per hr): 15 fold per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 2 x 0.1 ml Freund's complete adjuvant, 2 x 0.1 ml of a 10% solution of DBM in corn oil, and 2 x 0.1 ml 10% solution of 10% of DBM in corn oil with Freund's complete adjuvant.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 2 x 0.1 ml Freund's complete adjuvant, 2 x 0.1 ml of a 10% solution of DBM in corn oil, and 2 x 0.1 ml 10% solution of 10% of DBM in corn oil with Freund's complete adjuvant.
- No. of animals per dose:
- Ten control and 20 experimental animals
- Details on study design:
- The method followed was the Maximization Test" of Maganusson-Kligman. All animals received 6 intracutaneous injections into a 4 x 6 hair clipped skin area. Control only received corn oil.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 x 2 injections intracutaneously
- Exposure period: one week
- Test groups: 1
- Control group: 1
- Site: left and right shoulder
- Frequency of applications: 2
- Concentrations: 2 x 0.1 ml Freund's complete adjuvant, 2 x 0.1 ml of a 10% solution of DBM in corn oil, and 2 x 0.1 ml 10% solution of 10% of DBM in corn oil with Freund's complete adjuvant.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 7
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Site: shoulder
- Concentrations: undiluted
- Challenge controls:
- One week later the treated area was hair-clipped again and covered by a 2 x 4 cm filter paper containing 0.3 ml of pure DBM. Control only received a patch with corn oil. Two weeks later a filter paper patch (2 x 2 cm) containing corn oil or 0.2 ml pure DBM was placed on the hair-clipped left flank of both treated and control animals for 24 hours. The patch was removed 24 hours later.
- Positive control substance(s):
- no
- Remarks:
- Corn oil
Study design: in vivo (LLNA)
- Statistics:
- No specified.
Results and discussion
- Positive control results:
- A positive control was not tested. No effects were observed in the contro lgruop receiving corn oil only.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- pure corn oil
- 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: pure corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 ml of DBM
- No. with + reactions:
- 80
- Total no. in group:
- 20
- Clinical observations:
- erythema (grade 1 to 2)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 ml of DBM . No with. + reactions: 80.0. Total no. in groups: 20.0. Clinical observations: erythema (grade 1 to 2).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 ml of DBM
- No. with + reactions:
- 70
- Total no. in group:
- 20
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 ml of DBM. No with. + reactions: 70.0. Total no. in groups: 20.0. Clinical observations: erythema .
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the results, dibutyl maleate is a strong skin sensitizer in guinea pig.
- Executive summary:
The potential effect of skin sinsitization of dibutyl maleate was evaluated on female Albino Guinea pigs. Animals were exposed to 0.1 ml of 10% solution of the test substance in corn oil. A week later, a filter paper containing 0.2 ml of DBM was placed on the treated area. Two weeks later, the treated area was challenged with a filter paper containing 0.2 ml of pure DBM placed on the hair-clipped left flank of both treated and control animals for 24 hours. Observations showed that 80% of the animals developed erythema (grade 1 to 2) after 24 hours and 70% after 48 hours. Based on the results, it was concluded that dibutyl maleate is a skin sensitizer in Guinea pig.
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