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EC number: 203-561-1 | CAS number: 108-21-4
Skin sensitisation
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
- Justification for type of information:
- See attached justification below.
Cross-referenceopen allclose all
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- There were no significant deviations from the OECD protocol.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A reliable GPMT study was already available.
- Species:
- guinea pig
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen.
- Age at study initiation: Not specified
- Weight at study initiation: Test group average weight 328.5g, control 308.2g.
- Acclimation period: 4-8 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 60% +/-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- other: tested as 10% solution in maize germ oil for injection. 100% for topical application
- Details on study design:
- Test area prepared by clipping 6 hours before start of test. Dose 0.1ml. Sodium lauryl sulphate not used prior to topical application.
- No. of animals per dose:
- 20, 10 for control group.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none reported
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: not sensitizing
- Executive summary:
In a guideline (OECD 406) study, ethyl acetate was not sensitizing in the guinea pig maximization test.
General reactions did not occur during the test, the treatment had no detrimental effect on the development of body weight. (All individual animal weights reported at each significant time point.) After intracutaneous application: clear reddening, swelling and necroses at the injection sites treated with FCA and deionised water (1:1) (Test and control animals). Clear reddening and swelling at the injection sites treated with the 10% product in maize germ oil (Test). The control with just maize germ oil only showed slight reddening and swelling at the injection sites. Clear reddening and swelling and slight necroses at the injection sites treated with 10% product in a mixture of FCA and maize germ oil, 1:1 (Test) and those treated with FCA and maize germ oil, 1:1 (control). 2. After patch test with a contact duration of 48 h. Inflammation at all the injection sites treated with FCA. 24h after removal of the patch, crust formation at the injection sites.
- 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:
- 1988-02-02 - 1988-02-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Guideline study without GLP and with minor deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- : Reliability check is not given , control group consisted only of 9 animals
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A reliable GPMT study was already available.
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW albino
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 330,7 g
- Housing: 1 to 5 animals in Macrolon cages Typ IV
- Diet (e.g. ad libitum): G4 Allein diet for giunea pigs, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- Intradermal induction:
- FCA / water (1:1)
- 10% test substance in maize oil
- 10% test substance in maize oil and FCA (1:1)
epicutaneous induction (48 h):
- 100% test substance
challenge (24 h):
- 100% test substance - Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- Intradermal induction:
- FCA / water (1:1)
- 10% test substance in maize oil
- 10% test substance in maize oil and FCA (1:1)
epicutaneous induction (48 h):
- 100% test substance
challenge (24 h):
- 100% test substance - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection and topical application)
- Exposure period: topical application: 48 hr
- Test groups: Injection: TS in maize oil/FCA 1:1, topical application: TS loaded filter paper
- Control group: Injection: maize oil/FCA 1:1, topical application: patch loaded with maiz oil
- Site: shoulder region
- Frequency of applications: topical application 7 days after intradermal injection
- Concentrations: 10% TS in maize oil and pure TS respectively
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hr
- Test groups: pure TS on filter paper
- Control group: pure TS on filter paper
- Site: flank
- Evaluation (hr after challenge): 24 and 48 hr after end of exposure time - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Isobutyl acetate did not meet the criteria for a skin sensitizer according to Directive 2001/59/EC in a Guinea pig maximization test performed according to OECD TG 406
- Executive summary:
In a dermal sensitization study isobutyl acetate (purity ca 98%) was tested using a Guinea Pig Maximisation Test according to OECD test guideline 406 (Skin Sensitization), adopted 1981. 20 test animals were induced by intradermal injection of 0.1 mL of 10% TS in maize oil and and 0.1 mL of 10% TS in a 1:1 mixture of FCA and maize oil. For the topical application the injection site was treated 7days after the initial injection for 48 hours with pure TS (patch application). Challenge exposure followed after 14 days. Pure TS loaded on a patch was applied for 24 hours to one flank of the test animals. Reading of the skin reaction of test and control animals was taken 48 and 72 hours after the start of the challenge application.
For induction, controls (9 animals) were treated such as the test animals but with test mixtures without TS.
No skin reactions in any of the 20 test animals were observed either at 48 hours or at 72 hours after the start of the challenge application. There was no adverse effect on the development of the body weight of the test and control animals. In this study, isobutylacetate is not a dermal sensitizer.
This study is classified as reliable with restrictions due to minor deviatons from the OECD test guideline 406 (no reliability check, only 9 controls). In addition, it is not a GLP study. Yet the study results are considered to be valid since the deviations are only of little importance.
No skin reactions were observed in any of the 20 test animals neither at 48 hours nor at 72 hours after the start of the challenge application.
There was no adverse effect on the development of the body weight of the test and control animals.
Body weight development (mean of all animals in g)
| Test begin | Test end | Weight gain (three weeks) | |
| Test group | 330.7 | 446.1 | 115.4 |
| Controls | 335.0 | 472.4 | 137.4 |
During the test the following local reactions were observed:
Induction treatment - after intradermal injection
| test animals | controls | ||
| FCA / Water (1:1) | pronounced erythema and swelling as well as necrosis at the injection site | FCA / Water (1:1) | pronounced erythema and swelling as well as necrosis at the injection site |
| 10% TS in maize oil | pronounced erythema and swelling at the injection site | maize oil | slight erythema and swelling at the injection site |
| 10% TS in FCA / maize oil (1:1) | pronounced erythema and swelling as well as slight necrosis at the injection site | FCA / maize oil (1.1) | pronounced erythema and swelling as well as slight necrosis at the injection site |
Induction treatment - after topical application
Inflammation of all injection sites treated with FCA.
24 hours after patch removel scab formation at the injection site.
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well reported study in a peer reviewed journal. Some doubt about which isomer tested.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Mouse ear swelling test. Substance topically applied to shave body of animal on one or more daily occasions. 4 days after induction, test solution applied to one ear of mouse and inert vehicle to other ear as control. Difference in thickness of ears measured after 24 hrs from challenge and used as an indication of delayed type contact hypersensitivity response. Control animals that had not received the induction exposure also concurrently 'challenged' to check for unexpected irritation response.
- GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
- Justification for non-LLNA method:
- A reliable alternative study was already available.
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories or Harlan Sprague-Dawley.
- Age: 6-8 weeks
- Housing: 5 per wire bottomed stainless steel cage
- Diet ad libitum): Purina Lab rodent chow 5001
- Water ad libitum)
- Acclimation period: 1 week - Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction exposure: 100%
Challenge exposure: 50% - Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction exposure: 100%
Challenge exposure: 50% - No. of animals per dose:
- 10 test animals, 5 irritation control animals
- Details on study design:
- A. INDUCTION EXPOSURE
- two id injections of FCA totalling 50ul injected at test site.
- No. of exposures: 3 consecutive daily applications of 100ul of substance. Allowed to dry before animals returned to cages
- Site: shaved stomach area.
- Concentration: neat
B. CHALLENGE EXPOSURE
- Days after last induction exposure: 7
- No. of exposures: 1
- Exposure: single applications of 20ul of test substance to left ear of mouse. 20ul of vehicle control applied to right ear
- Site: left and right ears
- Concentrations: 50% (maximum that did not cause irritation.)
- Evaluation (hr after challenge): 24 and 48 hrs. Ear thickness measured using a spring loaded 'Oditest' guage (accurate to 10um) following light anaethetisation of animals. - Challenge controls:
- Right ears of test animals plus irritation controls
- Positive control substance(s):
- yes
- Remarks:
- cinammic aldehyde
- Positive control results:
- Other positive controls showed 100% of animals sensitised: these included toluene diisocyanate, oxazolone and N,N-dimethyl-p-nitrosoaniline.
- Reading:
- other: all readings combined
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- other: all readings combined
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
In a mouse ear swelling test, n-butyl acetate showed no evidence of sensitising potential.
Data source
Materials and methods
Test material
- Reference substance name:
- Isopropyl acetate
- EC Number:
- 203-561-1
- EC Name:
- Isopropyl acetate
- Cas Number:
- 108-21-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- isopropyl acetate
- Details on test material:
- - Name of test material (as cited in study report): isopropyl acetate
Constituent 1
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
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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.
