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Registration Dossier
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EC number: 247-655-0 | CAS number: 26399-02-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 6 Aug - 30 Aug 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (analytical purity of test substance not specified, no positive control group)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, no positive control group
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-ethylhexyl esters
- EC Number:
- 292-951-5
- EC Name:
- Fatty acids, C16-18, 2-ethylhexyl esters
- Cas Number:
- 91031-48-0
- Molecular formula:
- Not applicable, substance is a UVCB.
- IUPAC Name:
- Fatty acids, C16-18, 2-ethylhexyl esters
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given, Fatty acids, C16-18, 2-ethylhexyl esters
- Physical state: colourless liquid
- Analytical purity: no data
- Batch number: 90068
- Storage: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lebeau breeding centre, Gambais, France
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: male mean 436 g, female mean 423 g
- Housing: individual housing in polycarbonate cages
- Diet: guinea pigs sustenance ref. 106 (U.A.R., Villemoisson-sur-Orge, France), ad libitum
- Water: tap water, ad libitum
- Acclimation period: for a minimal period of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% at intradermal induction, 100% at epidermal induction, 50% at challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% at intradermal induction, 100% at epidermal induction, 50% at challenge
- No. of animals per dose:
- Treatment group: 20 (10 males and 10 females)
Control group: 10 (5 males and 5 females) - Details on study design:
- RANGE FINDING TESTS:
Based on the results of a preliminary study a 25% dilution of the test substance in paraffin oil was used for intradermal induction and the undiluted (100%) substance was used for the epidermal induction exposure. The undiluted test substance was found to be slightly irritating upon dermal application.
A 50% test substance concentration was selected for the challenge phase as the maximum non-irritant dose upon dermal exposure for 24 h under occlusive dressing.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction on day 1. On day 7 a local irritation was induced using 0.5 mL of a 10 % sodium laurylsulphate in vaseline. On day 8 a epidermal induction was performed with 0.5 mL vehicle or 0.5 mL test substance. The dermal applications were held in place for 48 hours under occlusive dressing.
- Test groups: 20 animals treated with test substance
- Control group: 10 animals treated with vehicle only
- Site: the scapular region of both sides
- Concentrations: 0.1 mL of 25% dilution of the test substance in paraffin oil in the presence of Freund' adjuvant was used for intradermal induction and 0.5 mL of the undiluted (100%) test substance was used for epidermal induction.
- Duration: 10 days
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 12 days after the last induction treatment
- Exposure period: 24 h under occlusive dressing
- Test groups: 20 animals treated with test substance
- Control group: 10 animals treated analogous to the test groups
- Site: the right flank was treated with the test substance; the left flank was treated with vehicle.
- Concentrations: 0.5 mL of a 50% solution in paraffin oil
- Evaluation (hr after challenge): 24 and 48 h after removal of the dressing - 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:
- 25% (intradermal induction, 50% (challenge)
- 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: 25% (intradermal induction, 50% (challenge) . 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:
- 25% (intradermal induction, 50% (challenge)
- 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: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (intradermal induction, 50% (challenge)
- 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: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (intradermal induction, 50% (challenge)
- 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: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
Table 1: Challenge readings
Group |
Sex |
Animals |
24 h scoring period |
48 h scoring period |
|||||||
Erythema |
Edema |
Erythema |
Edema |
||||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
||||
Control |
Males |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Females |
16 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
17 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
18 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
19 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Treated |
Males |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
11 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Females |
21 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
22 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
23 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
26 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
27 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
28 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
29 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
No deaths occured. No significant differences in the gain of body weight was observed between treatment and control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
A Guinea pig maximization test was performed according to OECD Guideline 406. 20 test and 10 control animals (Dunkin-Hartley guinea pigs) were induced with 25% substance solution and challenged with a 50% test substance solutionl. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications for a skin sensitising potential of Fatty acids, C16-18, 2-ethylhexyl esters.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
