Registration Dossier
Registration Dossier
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EC number: 241-240-8 | CAS number: 17199-29-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- see chapter 13 read across justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- L-2-hydroxy-2-phenylacetic acid
- EC Number:
- 210-276-6
- EC Name:
- L-2-hydroxy-2-phenylacetic acid
- Cas Number:
- 611-71-2
- Molecular formula:
- C8H8O3
- IUPAC Name:
- hydroxy(phenyl)acetic acid
- Reference substance name:
- Mandelic acid
- EC Number:
- 202-007-6
- EC Name:
- Mandelic acid
- Cas Number:
- 90-64-2
- Molecular formula:
- C8H8O3
- IUPAC Name:
- hydroxy(phenyl)acetic acid
- Details on test material:
- - Name of test material (as cited in study report): D-(-)-Mandelsaure, technisch rein
no further data
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.65-279 kg
- Housing: individually
- Diet: ca. 130 g/animal/day
- Water: ca. 250 ml/animal/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80 % aqueous formulation (w/w)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of the suspension
- Concentration (if solution): 80 % aqueous formulation (w/w) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24h/48h/72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: 2.5 xm x 2.5 cm
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- As no signs of irritation were observed, there is no need for classification of the test substance according to EU- and GHS-criteria. The test substance is not irritating to the skin.
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