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EC number: 603-931-6 | CAS number: 135800-37-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 24th, 1990 to August 16th, 1990
- 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:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no data on reliability check given
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Fatty acids, C8-16(even numbered), 2-ethylhexyl esters
- EC Number:
- 603-931-6
- Cas Number:
- 135800-37-2
- Molecular formula:
- C16H32O2 to C24H48O2
- IUPAC Name:
- Fatty acids, C8-16(even numbered), 2-ethylhexyl esters
- Details on test material:
- - Name of test material (as cited in study report): 2-ethyl-hexylester with fatty acids C8-C14
- Physical state: clear liquid
- Analytical purity: 100%
- Lot/batch No.: 8 of 1990
- Expiration date of the lot/batch: May 1992
- Storage condition of test material: RT
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Germany
- Age at study initiation: approx. 5 weeks
- Diet: ad libitum (Altromin Haltungsdiät 3032 DK)
- Water: ad libitum
- Weight at study initiation: male: mean 415 g
- Housing: 2-3 animals in Makrolon type IV cages
- Acclimation period: 5 days
- date of delivery: July 19th, 1990
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70%
- 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 on day 1: three pairs of intradermal injection were made symmetrically on each side of the spine and from cranial (1) to Caudal (3)
1. 0.1 mL 1:1 mixture of Freuds´complete adjuvant with water
2. 0.1 mL Test substance (5%) in peanut oil
3. 1:1 mixture of test article dilluted in FCA/water (5%)
- Controls recieved the same mixtures without the test article.
- The epidermal induction on day 7 was done with 40% test substance.
- Challenge: 20% test substance in paraffin oil
Concentrations were determined by preliminary testing
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- - Induction on day 1: three pairs of intradermal injection were made symmetrically on each side of the spine and from cranial (1) to Caudal (3)
1. 0.1 mL 1:1 mixture of Freuds´complete adjuvant with water
2. 0.1 mL Test substance (5%) in peanut oil
3. 1:1 mixture of test article dilluted in FCA/water (5%)
- Controls recieved the same mixtures without the test article.
- The epidermal induction on day 7 was done with 40% test substance.
- Challenge: 20% test substance in paraffin oil
Concentrations were determined by preliminary testing
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: Based on the results of a preliminary study a 0.5% dilution of the test substance in paraffine oil was used for intradermal induction and 40% of the test substance was used for the epidermal induction exposure. A 20% test substance concentration was selected for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction on day 1 and epidermal induction at day 7 (for 48 h)
- Test groups: 20 animals, TS
- Control group: 10 animals treated with vehicle
- Site: both sides of the spine
- Frequency of applications: once
- Concentrations: 5% dilution of the test substance in paraffine oil was used for intradermal induction and 40% used for epidermal induction.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22 (14 days after induction)
- Exposure period: 24 h
- Test groups: 20 animals, TS
- Control group: 10, treated like test groups
- Site: One sheared flank
- Concentrations: 20% solution in paraffin oil
- Evaluation (hrs after challenge):24 and 48 h - 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:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- One animal died after first induction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% . No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: One animal died after first induction.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- No
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: No.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- One animal died after first induction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: One animal died after first induction.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No.
Any other information on results incl. tables
Pilot study:
Intradermal: Minimal irritation at 0.5% of the test article
Dermal: Minimal irritation at 40%
Main study:
Intracutaneous induction: After one hour, weak effects were observed at 7 of 20 treated animals and none of the control animals. 24 h after treatment, 11 of 20 treated animals showed weak effekts and again non of the control animals.
Epicutaneous induction: After one hour, weak up to moderate skin reactions were observed at 16 of 19 treated animals (one died after exposure) and at 7 of 10 control animals. 24 h later mostly weak effects were observed at 10 treated animals and at 2 of the control animals.
Challenge readings - grades of skin reaction of individual animals
Animal No. |
Intracut. induction |
Epicut. induction |
Challenge |
|||
1 h |
24 h |
1 h |
24 h |
24 h |
48 h |
|
Control Animals |
||||||
27 |
0 |
0 |
1 |
0 |
1 |
0 |
28 |
0 |
0 |
1 |
0 |
1 |
0 |
29 |
0 |
0 |
1 |
0 |
0 |
0 |
30 |
0 |
0 |
1 |
0 |
0 |
0 |
31 |
0 |
0 |
0 |
0 |
1 |
0 |
32 |
0 |
0 |
2 |
1 |
0 |
0 |
33 |
0 |
0 |
1 |
1 |
1 |
0 |
34 |
0 |
0 |
0 |
0 |
1 |
1 |
35 |
0 |
0 |
0 |
0 |
0 |
0 |
36 |
0 |
0 |
1 |
0 |
0 |
0 |
Test Animals |
||||||
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
1 |
1 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
0 |
0 |
5 |
1 |
1 |
1 |
0 |
0 |
0 |
6 |
0 |
1 |
1 |
0 |
0 |
0 |
7 |
1 |
1 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
1 |
1 |
0 |
0 |
9 |
1 |
1 |
- |
- |
- |
- |
10 |
0 |
0 |
1 |
0 |
0 |
0 |
11 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0 |
1 |
2 |
1 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
0 |
0 |
15 |
1 |
0 |
0 |
0 |
0 |
0 |
16 |
0 |
1 |
2 |
2 |
1 |
0 |
17 |
0 |
0 |
1 |
1 |
0 |
0 |
18 |
0 |
1 |
2 |
2 |
0 |
0 |
19 |
0 |
1 |
0 |
0 |
0 |
0 |
20 |
1 |
0 |
1 |
1 |
0 |
0 |
One animal died after first exposure. 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 at test dose levels of 20 %
- Executive summary:
A Guinea pig maximization test was performed according to OECD Guideline 406. 19 test and 10 control animals (Dunkin-Hartley guinea pigs) were challenged with a 20 % 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 the test substance.
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