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EC number: 260-252-4 | CAS number: 56539-66-3
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- Ecotoxicological Summary
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- Short-term toxicity to fish
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Endpoint summary
Administrative data
Description of key information
A reliable in vivo study is available (Magnusson-Kligman maximisation test). The Based on the results of this study, 3 -methoxy-3 -methylbutan-1 -ol is considered not to have skin sensitising potential.
Furthermore MMB was found to have no photoirritation potential.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: T20-03: Magnusson-Kligman Maximization Test (Magnusson, B.,Kligman,A.M.,J.Invest.Dermat.,52,268-276,1969
- Version / remarks:
- 1969
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Magnusson-Kligman Maximization Test (Magnusson, B.,Kligman,A.M.,J.Invest.Dermat.,52,268-276,1969) with guinea pics was carried out or initiated before 11 October 2016. The test meets the requirements set out in Article 13(3), first subparagraph, and Article 13(4) and shall, therefore, be considered appropriate to address this standard information requirement for the skin sensitization endpoint.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: supplied by David Hall Ltd., Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Age at study initiation: young adult (less than one year old)
- Weight at study initiation: 421 to 494 g
- Housing: 5 per cage in main test group and control group; 4 per cage in range finding test
- Diet (e.g. ad libitum): ad libitum (FD1 Guinea Pig Diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex, CM8 3AD)
- Water (e.g. ad libitum): ad libitum (tab water)
- Acclimation period: 7 days prior to test commencement
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20 °C
- Humidity (%): 48 %
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark
IN-LIFE DATES: From: To: - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Distilled water
- Concentration / amount:
- INDUCTION
Intradermal: 10%
dermal: 100%
CHALLENGE
dermal: 100% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Distilled water
- Concentration / amount:
- INDUCTION Intradermal: 10% dermal: 100% CHALLENGE dermal: 100%
- No. of animals per dose:
- Test group 10 guinea pigs
Control group 10 guinea pigs
Challenge dose ranging group 4 guinea pigs - Details on study design:
- 1st application: Induction 10 % intracutaneous
2nd application: Induction 100 % open epicutaneous
3rd application: Challenge 100 % open epicutaneous - Positive control results:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- NA
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- NA
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- NA
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- NA
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- slight reaction
- Remarks on result:
- other: challenge
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no reaction
- Remarks on result:
- other: challenge
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible reaction
- Remarks on result:
- other: challenge
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible reaction
- Remarks on result:
- other: challenge
- Interpretation of results:
- not sensitising
- Conclusions:
- A well conducted, well reported guinea-pig skin sensitization test (Magnusson-Kligman method) reported that a 10% concentration of the test material in water induced no sensitization response when challenged with 100% of the test substance. Appropriate concurrent negative compliance controls were included.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 06-02-1991 until 17-03-1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted in compliance with GLP. The study was not conducted in accordance with an OECD guideline, however, the method used was based on that described in a published paper. The study was well performed and thoroughly described.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Harber, Armstrong, Ichikawa (JNCI, 1982, 69, 1).
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Freund's complete adjuvant test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall limited, Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire, UK.
- Age at study initiation: less than 1 year
- Weight at study initiation: order weight 300-350 g
- Housing: Housed to 5 in a cage, aluminium cages had grid floors beneath which were peat moss filled trays.
- Diet (e.g. ad libitum): FD1 Guinea pig diet, supplied by Special Diets Service, Witham, Essex, UK, hay were given ad libitum.
- Water (e.g. ad libitum): tap water ad libitum.
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C - 21°C
- Humidity (%): mean rel. humidity 52%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle - Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- Solfit concentration was 100% both for the induction and challenge exposure.
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- Solfit concentration was 100% both for the induction and challenge exposure.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
A preliminary test was performed with 5 previously untreated guinea pigs. They were exposed to 24h open epicutaneous topical applications of solfit at a concentration of 100%, 50%, 25% and 10% v/v in distilled water. The animals were exposed to 3 successive applications over 5 days. Test sites were assessed for irritation 24h after application of the test material using the scoring system described under the challenge procedure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 10 days
- Test groups: 1 test group
- Control group: 2 control groups
- Concentrations: 100% solfit
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Test groups: 1 test group
- Control group: 2 control groups
- Concentrations: 100% solfit
- Evaluation (hr after challenge): 24, 48, 72 hours
OTHER
Induction:
The test animals had hair removed from a 3 x 3cm area of the scapular region. 4 x 0.1 mL intradermal injections of Freund's Complete Adjuvant were administered at the corners of the shaved area.
Test animals: 0.1 mL of the test substance was applied open epicutaneously to the test site of each guinea pig. 30 minutes later, the test animals were exposed to UVA radiation through 3mm window glass (10.2 J * cm²).
The guinea pigs in control group 1 (see below for details) were similarly treated, but with distilled water instead of solfit.
The guinea pigs in control group 2 were treated with solfit but were not exposed to UVA radiation.
The procedure was repeated 4 further times.
Challenge:
20 days after the final induction exposure, the dorso lumbar area of the test animals was clipped and shaved. Four test sites were marked out on either side of the vertebral column of the test group and control group animals 1. 24h later 0.1 mL of solfit and the control material, distilled water, were applied to the prepared sites of the test and control group as described for the induction. The test sites on each animal were then covered with light proof tapel. For control group 2, the test material and the control material were applied, each to 2 prepared sites. The test group and control group 1 animals were exposed to UVA radiation after treatment. The test sites were assessed 24, 48 and 72hrs after irridation for evidence of erythmea and/or oedema using the following scoring system:
no reaction = 0
mild erythema without oedema = 1
moderate / strong erythema without oedema = 2
moderate/strong erythema with oedema = 3 - Challenge controls:
- see below
- Positive control substance(s):
- no
- Group:
- test chemical
- Dose level:
- 0.1 mL
- No. with + reactions:
- 0
- Clinical observations:
- No irritation was noted at any time in any of the test or control group animals. None of the test group or control group animals showed any positive response.
- Interpretation of results:
- not sensitising
- Conclusions:
- There is no evidence from the test results that Solfit is a photosensitiser in guinea pigs.
Referenceopen allclose all
Induction: Slight irritation was noted in the test group.
Challenge: Following challenge with the test material at a
concentration of 100%, none of the 10 test group showed
positive reactions to this application.
Induction:
No irritation was noted at any time in any of the test or control group animals. The injection sites showed normal erythemal responses.
Challenge:
None of the test group or control group animals showed any positive response.
Clinical signs:
No clinical signs, other than skin reactions induced by treament, were noted.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no reports of human skin or respiratory sensitisation associated with 3 -methoxy-3 -methyl-butan-1 -ol exposure.
A Magnusson-Kligman maximisation test is reported. The animals showed no irritation after the challenge with the neat test article, except for transient slight to moderate irritation on the animals at the intradermal induction with 10% (v/v) test article in water. Based on these results, 3 -methoxy-3 -methylbutan-1 -ol is considered not to have skin sensitising potential.
The photoirritation potential of MMB was investigated in guinea pigs. The substance was applied dermally in various concentrations followed by exposure to UVA light. No photoirritant responses were noted in the test and control groups.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data on respiratory sensitisation are available. However, in accordance with Section 1 of REACH Annex XI, the study is scientifically unjustified, as respiratory tract sensitisation is not expected based on the fact that 3 -methoxy-3 -methylbutan-1 -ol is not skin sensitizer and no human data are available indicating a concern for respiratory sensitisation.
Justification for classification or non-classification
Based on the absence of skin sensitising effect in a Kligman-Magnusson-Maximisation study with guinea pigs and the lack of data indicating the respiratory sensitisation of 3 -methoxy-3 -methylbutan-1 -ol, the substance is considered to be not sensitising according to Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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