Registration Dossier
Registration Dossier
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EC number: 469-910-7 | CAS number: 847842-48-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 17 December 1997 and 20 December 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Abacavir Hemisulphate
- IUPAC Name:
- Abacavir Hemisulphate
- Reference substance name:
- 188062-50-2
- Cas Number:
- 188062-50-2
- IUPAC Name:
- 188062-50-2
- Details on test material:
- - Name of test material (as cited in study report): 1592U89 Hemisulphate
- Molecular formula (if other than submission substance): Please see Attachment 1.
- Molecular weight (if other than submission substance): Please see Attachment 1.
- Structural formula attached as image file (if other than submission substance): Please see Attachment 1.
- Description: off white granular solid
- Batch number: R1136/156/1
- Date received: 24 November 1997
- Storage conditions: room temperature, in the dark, over silica gel
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK were used.
- Age at study initiation: Twelve to sixteen weeks old.
- Weight at study initiation: 2.61 to 2.76 kg
- Housing: Individually housed in suspended metal cages.
- Diet: ad libitum: STANRAB SQC Rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK
- Water: ad libitum: Mains drinking water.
- Acclimation period: Seven days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 20°C
- Humidity (%): 47 to 52%
- Air changes (per hr): Approximately 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light (light cycle 06.00 to 18.00) and 12 hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipped free of fur.
- Vehicle:
- water
- Remarks:
- Moistened with distilled water.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5g of the test material.
VEHICLE
- Amount(s) applied: Moistened with 1.0 mL of distilled water.
- Lot/batch no.: 97E19B26 - Duration of treatment / exposure:
- 4 hour exposure.
- Observation period:
- Approximately 1 hour following removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
- Number of animals:
- Three male animals.
- Details on study design:
- TEST SITE
- Area of exposure: Back of rabbit (dorsal/flank area).
- Type of wrap if used: 2.5 cm x 2.5 cm gauze patch secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm).
To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize J H, (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington, DC p.31.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Eschar
- Basis:
- animal: 60 Male
- Time point:
- other: Mean of 24, 48 and 72 hours.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects noted.
- Irritation parameter:
- erythema score
- Remarks:
- Eschar
- Basis:
- animal: 65 Male
- Time point:
- other: Mean of 24, 48 and 72 hours.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Effects noted at one hour.
- Irritation parameter:
- erythema score
- Remarks:
- Eschar
- Basis:
- animal: 69 Male
- Time point:
- other: Mean of 24, 48 and 72 hours.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Effects noted at one hour.
- Irritation parameter:
- edema score
- Basis:
- animal: 60 Male
- Time point:
- other: Mean of 24, 48 and 72 hours.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects noted.
- Irritation parameter:
- edema score
- Basis:
- animal: 65 Male
- Time point:
- other: Mean of 24, 48 and 72 hours.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects noted.
- Irritation parameter:
- edema score
- Basis:
- animal: 69 Male
- Time point:
- other: Mean of 24, 48 and 72 hours.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects noted.
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites at the 1-hour observation. No dermal reactions were noted at the 24-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not considered to be an irritant under the conditions of the study.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites. All treated skin sites appeared normal at the 24-hour observation.
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria necessary for classification as irritant or corrosive to the skin, according to EC labelling regulations.
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