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EC number: 939-514-3 | CAS number: 1471312-26-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Oct - 11 Nov 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. No individual irritation scores for induction period, no irritation score for the control site after challenge, animals were not weighed at the end of the study period.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no individual irritation scores for induction period, no irritation score for control site after challenge, animals not weighed at the end of the study period
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): (C12-C13) alkyl lactate
- Analytical purity: 100% (UVCB)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Padre Antonio, Mariano Comense, Italy
- Age at study initiation: young
- Weight at study initiation: approximately 200 - 300 g
- Housing: the guinea pigs were caged in groups of ten, in transparent polycarbonate cages (59.0 cm x 38.5 cm x 20.0 cm).
- Diet: standard pellet complete diet (MUCEDOLA), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 25 (maintained at a higher pressure than the outside atmosphere)
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18 Oct 1993 To: 11 Nov 1993
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Induction: undiluted
Challenge: undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Induction: undiluted
Challenge: undiluted
- No. of animals per dose:
- 10 (controls), 20 (in test groups)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: 0.1 mL 1:1 mixture FCA/water
Injection 2: 0.1 mL test substance in water (1:1)
Injection 3: 0.1 mL test substance in a 1:1 mixture FCA/water
Epicutaneous (one occlusive patch): 0.5 mL undiluted test substance
- Control group:
Intradermal (3 pairs of injections):
Injection 1: 0.1 mL 1:1 mixture FCA/water
Injection 2: 0.1 mL water
Injection 3: 0.1 mL water and FCA in a 1:1 ratio
Epicutaneous (one occlusive patch): 0.5 mL water
- Site: injections were made in the subscapular region, on each side of the midline; patch was placed caudally to the area of injection.
- Frequency of applications: twice (intradermal injection on Day 0, epicutanous application on Day 7)
- Duration: Day 0-7
- Concentrations: intradermal 50%, epicutaneous: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 h
- Test groups: test substance and water
- Control group: test substance and water
- Site: test material was applied to the right flank, water was applied to the left flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24, 48 and 72 h after patch removal
OTHER: a 50 cm² skin site was shaved 24 h prior to the first induction treatment. It is unclear if the animals has slight erythema during the whole study period, and therefore unclear if SDS should have been used prior to the second induction treatment to cause skin irritation. - Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- A reliability check is performed at regular intervals to check the sensitivity of the test system and the reliability of the experimental techniques of the contract laboratory. In an independent study performed in November 1993, mercaptobenzothiazole induced sensitisation in 4/10 (40%) of the positive control animals. 0/5 negative control animals showed skin sensitisation. All the guinea pigs were treated with sodium lauryl sulfate prior to the topical induction.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 100%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Scattered mild redness (score 1 of 3)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 100%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Scattered mild redness (score 1 of 3).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 50%; challenge: 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Scattered mild redness (score 1 of 3)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 50%; challenge: 100%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Scattered mild redness (score 1 of 3).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 100%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Scattered mild redness (score 1 of 3)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 100%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Scattered mild redness (score 1 of 3).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 50%; challenge: 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Scattered mild redness (score 1 of 3)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 50%; challenge: 100%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Scattered mild redness (score 1 of 3).
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 100%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Scattered mild redness (score 1 of 3)
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: induction: 0%; challenge: 100%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Scattered mild redness (score 1 of 3).
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction: 50%; challenge: 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Scattered mild redness (score 1 of 3)
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: induction: 50%; challenge: 100%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Scattered mild redness (score 1 of 3).
Any other information on results incl. tables
20/20 animals in the treatment group and 10/10 animals in the control group had scattered mild redness (skin irritation score 1 of 3) at the 24 -, 48- and 72 hour reading time points after the challenge treatment (see Table 2 and 3).
This erythema is considered an irritant effect, and not a sensitising effect.
Table 2: individual scores after challenge treatment, treatment group
Animal No. |
Reading time point (h after challenge ended) |
||
|
24 |
48 |
72 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
4 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
6 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
9 |
1 |
1 |
1 |
10 |
1 |
1 |
1 |
11 |
1 |
1 |
1 |
12 |
1 |
1 |
1 |
13 |
1 |
1 |
1 |
14 |
1 |
1 |
1 |
15 |
1 |
1 |
1 |
16 |
1 |
1 |
1 |
17 |
1 |
1 |
1 |
18 |
1 |
1 |
1 |
19 |
1 |
1 |
1 |
20 |
1 |
1 |
1 |
Table 3: individual scores after challenge treatment, control group
Animal No. |
Reading time point (h after challenge ended) |
||
|
24 |
48 |
72 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
4 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
6 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
9 |
1 |
1 |
1 |
10 |
1 |
1 |
1 |
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
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