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EC number: 412-540-8 | CAS number: 22471-55-2 ET 344 SP
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Information provided in SNIF file. Study was conducted prior to the mandatory requirement to conduct LLNA over in vivo methods
Test material
- Reference substance name:
- Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate
- EC Number:
- 412-540-8
- EC Name:
- Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate
- Cas Number:
- 22471-55-2
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- ethyl trans-2,2,6-trimethylcyclohexanecarboxylate
- Reference substance name:
- Ethyl cis-2,2,6-trimethylcyclohexane-1-carboxylate
- Molecular formula:
- C12H22O2
- IUPAC Name:
- Ethyl cis-2,2,6-trimethylcyclohexane-1-carboxylate
- Reference substance name:
- Unidentified impurities
- Molecular formula:
- Not specified.
- IUPAC Name:
- Unidentified impurities
- Test material form:
- liquid: viscous
- Details on test material:
- Test material identification : ET-344 SP
Chemical name : Ethyl 2,2,6-trimethyl cyclohexanecarboxylate
Description: Clear, colourless liquid
Date received: 2 November 1992
Container: Metal bottle x3
Storage conditions: Room temperature
Constituent 1
Constituent 2
impurity 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Specification
Thirty-eight female, albino Dunkin-Hartley guinea pigs were supplied by David Hall Limited, Burton-on-Trent, Staffordshire, U.K. At the start of the main study the animals weighed 316 -438g, and were approximately eight to twelve weeks old. After a minimum acclimatisation period of five days, each animal was selected at random and given a number unique within the study which was written on a small area of clipped rump using a black indelible marker-pen.
Husbandry
The animals were housed in groups of up to three in solid-floor polypropylene cages furnished with softwood shavings. Free access to mains tap water and food (Guinea Pig FDl Diet, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.The animal room was maintained at a temperature of 18 - 21°C and relative humidity of 32 - 56%. On occasions the temperature was below the limit specified in the protocol (19°C). This was considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 25% (w/v) in arachis oil B.P.
25% (w/v) in a mixture of Freund's
Complete Adjuvant plus arachis oil B.P. (1:1) - Day(s)/duration:
- Day 7: intradermal dose
- Adequacy of induction:
- other: The highest concentration that did not cause local necrosis, ulceration or systemic toxicity.
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Undiluted as supplied
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 75% (v/v) in arachis oil B.P.
- Day(s)/duration:
- Challenge dose on day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 50% (v/v) in arachis oil B.P.
- Day(s)/duration:
- Challenge dose on day 21
- Adequacy of challenge:
- other: The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- The method used for assessing the sensitising properties of the test material was based on the Guinea Pig Maximisation test of Magnusson B. & Kligman A.M., J. Invest. Dermatol. (1969) 52: 268 - 276.
Selection of Concentrations for Main Study (Sighting Tests)
The concentrations of test material to be used at each stage of the main study were determined by 'sighting tests' in which groups of guinea pigs were treated with various concentrations of test material . The procedures were as follows:
a) Selection of Concentration for Intradermal Induction
Four animals were intradermally injected with preparations of test material (1%, 5%, 10% or 25% w/v in arachis oil B.P.). The highest concentration that did not cause local necrosis, ulceration or systemic toxicity, was selected for the intradermal induction stage of the main study.
b) Selection of Concentration for Topical InductionTwo guinea pigs (intradermally injected with Freund's Complete Adjuvant ten days earlier) were treated with the undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in arachis oil B.P.).The highest concentration producing only mild to moderate dermal irritation after a 48-hour occlusive exposure, was selected for the topical induction stage of the main study.Selection of Concentration for Topical Challenge
The undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in arachis oil B.P.) were applied occlusively to the flanks of two guinea pigs for a period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
Main Study
A group of thirty guinea pigs was used for the main study, twenty test and ten control. The bodyweight of each animal was recorded at the start and end of the study.
Two main procedures were involved in the maximisation test;
(a) an induction of a response and (b) a challenge of that response.a) InductionInduction of the Test Animals: Shortly before treatment on Day 0 the hair was removed from an area approximately 40 mm X 60 mm on the shoulder region of each animal with veterinary clippers. A row of three injections (0.1 mL each) was made on each side of the mid-line. The injections are reported above. One week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material. The undiluted test material (0.2 - 0.3 ml) was applied on filter paper (WHATMAN No.4: approximate size 40 mm X 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 60 mm X 25 mm) and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm X 35 mm) wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours.Erythematous reactions were quantified one and twenty-four hours following removal of the patches using the 0 - 3 scale: 0 - no reaction / l - scattered mild redness / 2 - moderate and diffuse redness / 3 - intense redness and swelling Induction of the Control Animals : Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were as reported above. The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper.Skin reactions were quantified as for the test animals.
b) Challenge
Shortly before treatment on Day 21, an area, approximately 50 mm X 70 mm on both flanks of each animal, was clipped free of hair with veterinary clippers.A quantity of 0.1 - 0.2 mL of the test material formulation (75% v/v in arachis oil B.P.) was applied to the shorn right flank of each animal on a square of filter paper (WHATMAN No.4: approximate size 20 mm X 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 40 mm X 50 mm). To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 50% (v/v) in arachis oil B.P. was also similarly applied to a separate skin site on the right shorn flank. The vehicle alone was similarly applied to the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm X 75 mm) wound in a double layer around the torso of each animal.After 24 hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The challenge sites were swabbed with cotton wool soaked in diethyl ether to remove residual material. The vehicle sites were similarly swabbed. The position of the treatment sites was identified by using a black indelible marker-pen. Prior to the 24-hour observation the flanks were clipped using veterinary clippers to remove regrown hair.
c) Evaluation of Skin Reactions
Approximately 24 and 48 hours after challenge dressing removal erythematous reactions were quantified using the four-point scale. - Challenge controls:
- The vehicle alone was applied as a control.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
a) Skin Reactions Observed After Topical Induction
Scattered mild redness was elicited by the test material.
b) Skin Reactions Observed After Topical Challenqe
75% (v/v) in Arachis Oil B.P.
A positive skin response (redness grade 1) was noted at the challenge site of one test group animal at the 24-hour observation.
No skin reactions were noted at the challenge sites of test group animals at the 48-hour observation and at the challenge sites of control group animals at the 24 and 48-hour observations.
50% (v/v) in Arachis Oil B.P.
A positive skin response (redness grade 1) was noted at the challenge site of one test group animal at the 24-hour observation.
No skin reactions were noted at the challenge sites of test group animals at the 48-hour observation and at the challenge sites of control group animals at the 24 and 48-hour observations.
Vehicle Control
No skin reactions were noted at the vehicle control sites of the test or control group animals at the 24 and 48-hour observations.
Bodyweight
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, ET-344 SP, produced a 10% (2/20) sensitisation rate. The test material does not need to be classified according to the CLP criteria.
- Executive summary:
A study was performed to assess the skin contact sensitisation potential of the test material in the albino guinea pig. The method used followed that described in the OECD Guidelines for Testing o f Chemicals (1981) No. 406 "Skin Sensitisation" - Magnusson and Kligman Maximisation Test referenced as Method B6 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
Twenty test and ten control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as
follows :
Intradermal Induction: 25% (w/v) in arachis o i l B.P.
Topical Induction : undiluted as supplied
Topical Challenge : 75% and 50% (v/v) in arachis oil B.P.
The test material produced a 10% (2/20) sensitisation rate.
The test mateial does not need to be classified according to the CLP criteria.
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