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EC number: 295-366-3 | CAS number: 92044-87-6
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:
- 24 Jul - 16 Aug 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions. No data given about the reliability check.
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 given on reliability check
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data already available
Test material
- Reference substance name:
- 135800-37-2
- EC Number:
- 603-931-6
- Cas Number:
- 135800-37-2
- IUPAC Name:
- 135800-37-2
- Details on test material:
- - Name of test material (as cited in study report): Trade name; 2-ethyl-hexylester with fatty acids C8-C14
- Physical state: clear liquid
- Analytical purity: 100%
- Lot/batch No.: 8 of May 1990
- Expiration date of the lot/batch: May 1992
- Stability under test conditions: stable for at least 2 years, stable in water
- Storage condition of test material: room temperature
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 Versuchstierzucht, Borchen, Germany
- Age at study initiation: approx. 5 weeks
- Diet: Altromin Haltungsdiät 3032 DK, Lage, Germany, ad libitum; with additive carrots
- Water: tap water with an additive of ascorbic acid (1 g/L), ad libitum
- Mean weight at study initiation: 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:
- Preliminary study:
Intracutaneous induction: 0.5, 1 and 2%
Epicutaneous induction and retreatment: 40, 50, 60 and 70%
Main study:
Intracutaneous induction: 0.5%
Epicutaneous induction: 40%
Challenge: 20%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Preliminary study:
Intracutaneous induction: 0.5, 1 and 2%
Epicutaneous induction and retreatment: 40, 50, 60 and 70%
Main study:
Intracutaneous induction: 0.5%
Epicutaneous induction: 40%
Challenge: 20%
- No. of animals per dose:
- Preliminary study: 2 animals
Main study:
Test group: 20 females
Control group: 10 females - Details on study design:
- RANGE FINDING TESTS: Yes, evaluation of dermal effects was done by treating the animals with 0.5%, 1% or 2% for intracutaneous induction (injection of 0.1 mL into the shaved flank) and 40%, 50%, 60% or 70% for epicutaneous induction and retreatment of the test substance (0.08 g on the shaved flank) and observation of irritating effects 24 h and 48 h after treatment.
Intradermal: Minimal irritation at 0.5% of the test article
Dermal: Minimal irritation at 40%
Based on the results of the preliminary study the minimal irritating concentrations, 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 as maximally non-irritating for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single application (intradermal induction on Day 1) and 48 hours (epidermal induction on Day 7)
- Test groups: 1
Intradermal (double injections):
Injection 1: 0.1 mL 1:1 mixture (v/v) Freuds'complete adjuvant (FCA) in paraffin oil
Injection 2: 0.1 mL test substance with vehicle (paraffin oil) in concentration minimally irritating (5%)
Injection 3: 0.1 mL test substance in a 1:1 mixture (v/v) with FCA (final concentrations: test substance minimally irritating (5%), FCA 50%)
Epicutaneous: test substance (40%) with vehicle (paraffin oil)
- Control group: 1
Intradermal (double injections; the injections 1 and 3 were identical):
Injection 1 and 3: a 1:1 mixture (v/v) FCA in paraffin oil
Injection 2: only vehicle (paraffin oil)
Epicutaneous: vehicle (paraffin oil)
- Site: symmetrically on both sides of the spine and from cranial to cauda
- Frequency of applications: once
- Concentrations: intradermal: 0.5%, epicutaneous: 40%
- Other: An examination of the injections was performed 1 and 24 hours after treatment.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22 (14 days after induction)
- Exposure period: 24 h
- Test groups: test substance and vehicle (paraffin oil)
- Control group: test substance and vehicle (paraffin oil)
- Site: One sheared flank
- Concentrations: 20% solution in paraffin oil
- Evaluation (hrs after the end of the challenge exposure): 24 and 48 h
- Other: 24 hrs after challenge application the application area was washed off with warm water - 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
Main study:
Intracutaneous induction: After one hour, weak effects were observed in 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 none of the control animals.
Epicutaneous induction: After one hour, weak up to moderate skin reactions were observed in 16 of 19 treated animals (one died after exposure) and in 7 of 10 control animals. 24 h later mostly weak effects were observed in 10 treated animals and in 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
- Conclusions:
- CLP: not classified
DSD: not classified
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