Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 292-951-5 | CAS number: 91031-48-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 6th, 1991 - August 30th, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
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)
- Deviations:
- yes
- Remarks:
- ; lack of details on test substance; no data on reliability check
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
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:
- 91031-48-0
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, C16-18, 2-ethylhexyl esters
- Physical state: colourless liquid
- Batch number: 90068
- Storage: at room temperature
- No further details given.
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 (e.g. ad libitum): ad libitum (guinea pigs sustenance ref. 106 (U.A.R., France)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- 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:
- Induction: three pairs of intradermal injection (One of each pair was injected on each side of the midline and from cranial (1) to Caudal (3)
1. 1:1 mixture of Freuds´complete adjuvant with 0.9% sodium chloride
2. Test substance (25%) in paraffin oil
3. 1:1 mixture of the undiluted test substance with Freuds´complete adjuvant and 0.9% sodium chloride
The epidermal induction was done with 100% test substance 24 h after a local irritation with sodium lauryl sulphate in vaseline
Challenge: 50% test substance in paraffin oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: three pairs of intradermal injection (One of each pair was injected on each side of the midline and from cranial (1) to Caudal (3)
1. 1:1 mixture of Freuds´complete adjuvant with 0.9% sodium chloride
2. Test substance (25%) in paraffin oil
3. 1:1 mixture of the undiluted test substance with Freuds´complete adjuvant and 0.9% sodium chloride
The epidermal induction was done with 100% test substance 24 h after a local irritation with sodium lauryl sulphate in vaseline
Challenge: 50% test substance in paraffin oil
- No. of animals per dose:
- 20
- 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, TS
- 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 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, TS
- Control group: 10, 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:
- 50 %
- 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: 50 %. 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:
- 50 %
- 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: 50 %. 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:
- 50 %
- 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: 50 %. 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:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
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 Under the given conditions the test substance was not sensitising to guinea pig skin.
- 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 challenged with a 50 % test substance solution in paraffin oil. 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.
