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EC number: 701-133-3 | CAS number: -
Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- 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)
- 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 valid skin sensitisation study was available from 1991 (before REACh came into force) and therefore no additional LLNA test was performed.
- 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 - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% at intradermal induction, 100% at epidermal induction, 50% at challenge
- 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
- 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.
- 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 solution. 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.
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.
Data source
Materials and methods
Test material
- Details on test material:
- - Name of test material (as cited in study report): Isononyl Isononanoate
- Physical state: liquid
Constituent 1
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:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (intr adermal 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:
- test chemical
- Dose level:
- 25% (intradermal induction, 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (intr adermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Conclusions:
- Taking all the available data into consideration, isononyl isononanoate is considered not to be a skin sensitiser.
- Executive summary:
No studies assessing the skin sensitising properties of isononyl isononanoate are available. A Guinea Pig Maximisation Test was performed with the analogue substance Fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0), in which no skin sensitisation was induced (Clouzeau, 1991). The results of a Repeated Insult Patch Test (epicutaneous test) performed in 98 human volunteers with the analogue substance 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) show the substance had no skin sensitising effects (Harrison, 1997).
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