Registration Dossier
Registration Dossier
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EC number: 248-363-6 | CAS number: 27247-96-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 November 1987 to 14 January 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl nitrate
- EC Number:
- 248-363-6
- EC Name:
- 2-ethylhexyl nitrate
- Cas Number:
- 27247-96-7
- Molecular formula:
- C8H17NO3
- IUPAC Name:
- 2-ethylhexyl nitrate
- Test material form:
- liquid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine (France)
- Age at study initiation: not indicated
- Weight at study initiation: mean body weight of 2.5 +/- 0.1 kg
- Housing: polystyrene cages
- Diet (e.g. ad libitum): pelleted diet
- Water (e.g. ad libitum): drinking water filtered by a membrane (0.22 microns)
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 50% +/- 20%
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From 10 November 1987 to 16 November 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left flank was not treated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL on the right flank of each animal
VEHICLE
Test substance applied as it. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 6 animals
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing
SCORING SYSTEM:
Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No cutaneous reactions were observed 1 hour and 24 hours after patch removal.
Very slightly erythema was noted in one male (number 6) at 48 hours, and in two animals (number 3 and 6) at 72 and 96 hours.
On days 6, only animal number 6 showed very slightly erythema. No cutaneous reactions were noted in any animals.
No oedema was observed in any animals during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In the experimental conditions of the study, the test item was considered to be not irritating to the skin.
- Executive summary:
In the experimental conditions of the study, the test item was considered to be not irritating to the skin.
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