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EC number: 253-657-2 | CAS number: 37763-23-8
- 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
- Study period:
- end on 18-AUG-2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed according to OECD guideline and GLP. In the end nineties Deretil has noticed that in particular esters resulted in positive M&K tests, whereas the practice did not show any effect. Deeper analysis by an expert and of existing studies revealed that the use of corn oil could be the cause of that. Therefore we decided to redo the test for HPGM with 1% aqueous carboxymethylcellulose.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Methyl (R)-amino(4-hydroxyphenyl)acetate
- EC Number:
- 253-657-2
- EC Name:
- Methyl (R)-amino(4-hydroxyphenyl)acetate
- Cas Number:
- 37763-23-8
- Molecular formula:
- C9H11NO3
- IUPAC Name:
- methyl (2R)-2-amino-2-(4-hydroxyphenyl)acetate
- Details on test material:
- - Name of test material (as cited in study report): HPGM
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: < 500 grams
- Housing: group housing of 5 animals per labelled metal cage with wire-mesh floors
- Diet: Free access to standard guinea pig diet, including ascorbic acid (1000 mg/kg)
- Water: Free access to tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature 21 °C
- Humidity: 70%
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day
(deviations from these optima conditions were noted, but were considered not to have affected study integrity)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Concentration / amount:
- induction (intradermal): 2%
induction (epidermal): 50%
challenge (epidermal): 25% (1st challenge) and 25%, 10%, 5% (2nd challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- induction (intradermal): 2%
induction (epidermal): 50%
challenge (epidermal): 25% (1st challenge) and 25%, 10%, 5% (2nd challenge)
- No. of animals per dose:
- Experimental group: 10 females.
Control group: 5 females. - Details on study design:
- RANGE FINDING TESTS:
Prior to the start of the Main study, the intradermal and epidermal irritancy of FGHM was investigated to select test substance concentrations suitable for the induction and challenge phase o f the Main Study.
Intradermal injections:
A series of four test substance concentration was used, the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1mL/site) in the clipped scapular region. The injected site were assessed for irritation 24 and 48h after treatment.
Epidermal application:
A series of four test substance concentration was used the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5mL each) per animal to the clipped flank, using Metalline Patches mounted on medical tape which were held in place with Micropore tape and subsequently Coban elastic bandage.
The animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations.
After 24h, the dressing was removed and the skin cleaned of residual test substance using water. The treated skin areas were assessed for irritation 24 and 48h after exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
INDUCTION - Experimental animals:
Day 1 The scapular region was clipped and three pairs of intradermal injections (0.1 ml/site) were made in this area as follows:
A) A 1 :1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.) with water for injection (Fresenius AG, Bad Homburg, Germany).
B) The test substance at a 2 % concentration.
C) A 1 :1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant.
Day 3 The dermal reactions caused by the intradermal injections were assessed for irritation.
Day 8 The scapular area between the injection sites was treated with 0.5ml of a 50% test substance concentration using a Metalline patch (2x3cm) mounted on Metalline tape and secured with Coban elastic bandage.
The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance with water and the dermal reactions caused by the epidermal exposure were assessed for irritation.
INDUCTION - Control animals:
The control animals were treated as described for the experimental animals except that, instead of the test substance, vehicle alone was administered.
B. CHALLENGE EXPOSURE (all animals)
Day 21 All animals were treated epidermally with 0.15 ml at test substance concentration of 50 % on a clipped flank , using Patch test Plasters, attached to Micropore tape and secured with Coban elastic bandage.
The dressing was removed after 24h exposure and the skin cleaned of residual test substance and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48h after removal of the dressing.
Day 28 A re-challenge was conducted approximately one week after the first challenge. The contralateral flank of all animals was similarly treated, except that multiple test substance concentrations and the vehicle were applied. All animals were treated epidermally with 0.15mL of each of the following concentrations, 25%, 10% and 5% and the vehicle.
The dressing was removed after 24h exposure and the skin cleaned of residual test substance and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48h after removal of the dressing. - Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMICALDEHYDE
Results and discussion
- Positive control results:
- The skin reactions in the experimental animals observed in response to the 10% test substance concentrations in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.
These results lead to a sensitisation rate of 80 per cent for the 10% concentration.
From these results, it was concluded that the female guinea pig of the albino Dunkin Hartley strain is an appropriate animal model for the performance of studies designed to evaluate the sensitising potential of a substance in a Maximisation type of test.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effect
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effect.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effect
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effect.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%, 10%, 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effect
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25%, 10%, 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effect.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%, 10%, 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effect
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%, 10%, 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effect.
- Reading:
- other: 1st and 2nd challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%, 10%, 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effect
- Remarks on result:
- other: Reading: other: 1st and 2nd challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%, 10%, 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effect.
Any other information on results incl. tables
Challenge phase:
First challenge: No skin reactions were evident after the challenge exposure to the 25% test substance concentration in the experimental and control animals.
Second challenge: No skin reactions were evident after the challenge exposure to the 25%, 10% and 5% test substance concentrations in the experimental and control animals.
Toxicity Symptoms / Mortality:
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Body Weights:
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Table 1: results of first challenge reading
Animal number |
Day 23 |
Day 24 |
Comments |
||
25% |
Vehicle |
25% |
Vehicle |
||
Control |
|||||
136 |
0 |
0 |
0 |
0 |
|
137 |
0 |
0 |
0 |
0 |
|
138 |
0 |
0 |
0 |
0 |
|
139 |
0 |
0 |
0 |
0 |
|
140 |
0 |
0 |
0 |
0 |
|
Experimental |
|||||
141 |
0 |
0 |
0 |
0 |
Not sensitised |
142 |
0 |
0 |
0 |
0 |
Not sensitised |
143 |
0 |
0 |
0 |
0 |
Not sensitised |
144 |
0 |
0 |
0 |
0 |
Not sensitised |
145 |
0 |
0 |
0 |
0 |
Not sensitised |
146 |
0 |
0 |
0 |
0 |
Not sensitised |
147 |
0 |
0 |
0 |
0 |
Not sensitised |
148 |
0 |
0 |
0 |
0 |
Not sensitised |
149 |
0 |
0 |
0 |
0 |
Not sensitised |
150 |
0 |
0 |
0 |
0 |
Not sensitised |
Table 2: results of second challenge reading
Animal number |
Day 30 |
Day 31 |
Comments |
||||||
25% |
10% |
5% |
Vehicle |
25% |
10% |
5% |
Vehicle |
||
Control |
|||||||||
136 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
137 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
138 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
139 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
140 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Experimental |
|||||||||
141 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
142 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
143 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
144 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
145 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
146 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
147 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
148 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
149 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
150 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitised |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- not sensitising to the skin
- Executive summary:
In a dermal sensitization study with HPGM in 1% aqueous carboxymethylcellulose, young adult Dunkin Hartley guinea pigs (10+5 females) were tested using the method of Maximisation (OECD 406, GLP).
Test substance concentrations selected for the Main study were based on the results of a preliminary study.
In the Main study, ten experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle only. Two weeks after the epidermal application all animals were challenged with a 25% test substance concentration and the vehicle. A second challenge was performed one week later at 25%, 10%, 5% and vehicle.
Challenge phase:
First challenge: No skin reactions were evident after the challenge exposure to the 25% test substance concentration in the experimental and control animals.
Second challenge: No skin reactions were evident after the challenge exposure to the 25%, 10% and 5% test substance concentrations in the experimental and control animals.
Toxicity Symptoms / Mortality:
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Body Weights:
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
There was no evidence that HPGM had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the first and second challenge phase to any of the test substance concentrations tested.
The result indicates a sensitisation rate of 0%.
Based on these results, HPGM does not have to be classified as sensitising to the skin according to EU criteria (DSD and CLP regulation).
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