Registration Dossier
Registration Dossier
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EC number: 266-959-4 | CAS number: 67707-75-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- from 6th of June to 1st of July fo 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no data if induction produced irritation reaction + no pretreatment
- GLP compliance:
- no
- Remarks:
- study performed before implementation of GLP at OECD level
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- test conducted before first publication of OECD 429 (LLNA test)
Test material
- Reference substance name:
- Ethyl 3,5,5-trimethylhexanoate
- EC Number:
- 266-959-4
- EC Name:
- Ethyl 3,5,5-trimethylhexanoate
- Cas Number:
- 67707-75-9
- Molecular formula:
- C11H22O2
- IUPAC Name:
- ethyl 3,5,5-trimethylhexanoate
- Details on test material:
- - Name of test material: 3,5,5-Trimethyl-ethyl capronate
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Weight at study initiation: 396 g (mean, test group), 400 g (mean, control group)
- Housing: in groups of 5 in Makrolon cages, type 4
- Diet (e.g. ad libitum): guinea pig diet Altromin 3022, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21
- Humidity (%): approx. 50
- Air changes (per hr): 11
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: propylen glycol (intradermal / challenge), vaseline (epicutaneous)
- Concentration / amount:
- intradermal induction: 5% in propylene glycol,
epicutaneous induction: 5% in vaseline,
challenge: 1% in propylen glycol
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: propylen glycol (intradermal / challenge), vaseline (epicutaneous)
- Concentration / amount:
- intradermal induction: 5% in propylene glycol,
epicutaneous induction: 5% in vaseline,
challenge: 1% in propylen glycol
- No. of animals per dose:
- 20 (test group), 20 (control)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 dermal
- Exposure period: 48 h (dermal)
- Test groups: 5% test substance
- Control group: propylene glycol (intradermal) / vaseline (epicutaneous)
- Site: above the shoulder blades
- Concentrations:
Intradermal:
0.1 mL FCA (mixed at a ratio of 1+1 in vehicle)
0.1 mL 5% test substance in propylene glycol
0.1 mL 5% test substance + FCA (mixed at a ratio of 1+1 in propylene glycol)
Epicutaneous:
5% in vaseline
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: day 22 (14 d after epicutaneous induction)
- Exposure period: 24 h
- Test groups: right flank: propylene glycol, left flank: test substance 1% in propylene glycol
- Control group: right flank: propylene glycol, left flank: test substance 1% in propylene glycol
- Evaluation (hr after challenge): 24, 48
OTHER: no pretreatment with irritating substance / no information whether substance at applied concentration was minimally irritating as stipulated in the guideline - 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:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- one animal found dead 24 h after challenge
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: one animal found dead 24 h after challenge.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- one animal found dead 24 h after challenge
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: one animal found dead 24 h after challenge.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 3,5,5-Trimethyl-ethyl capronate was not sensitising in this study.
- Executive summary:
In a dermal sensitisation study similar to OECD guideline 406 with 3,5,5-Trimethyl-ethyl capronate, 20 female Pirbright white guinea pigswere tested using the method of method of Magnusson & Kligman (Guinea Pig Maximisation Test).
Intradermal induction was performed with 5% in propylene glycol, epicutaneous induction with 5% in vaseline, challenge with 1% in propylen glycol. The animals were not pretreated to generate local irritation before epicutaneous induction.
After challenge no visible changes of the treated skin sites were observed in the test and control group animals 24 and 48 h after patch removal (= grade 0).
The test material produced a response in 0% of animals. According to CLP, EU GHS (Regulation (EC) No 1272/2008), a response of at least 30% of the test animals of an adjuvant type guinea pig test method for skin sensitisation is considered as positive.
Therefore 3,5,5-Trimethyl-ethyl capronate is not a dermal sensitiser in this study.
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