Registration Dossier
Registration Dossier
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EC number: 228-408-6 | CAS number: 6259-76-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - June 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexyl salicylate
- EC Number:
- 228-408-6
- EC Name:
- Hexyl salicylate
- Cas Number:
- 6259-76-3
- Molecular formula:
- C13H18O3
- IUPAC Name:
- hexyl salicylate
- Details on test material:
- - Name of test material (as cited in study report): Hexyl salicylate
- Analytical purity: One sample was 50% solution in DEP and the other was 100% pure
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A Smith, Waringham, Surrey, England
- Housing: Individually housed in anodised aluminum cages with grid floors and no bedding material
- Diet (e.g. ad libitum): commercially available pelleted rabbit diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-67
- Photoperiod (hrs dark / hrs light): 12 hr light/ 12 hr dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Total 168 hours. Animals were observed at 1, 24, 48, 72, and 168 hours after patch removal
- Number of animals:
- 4 animals per group
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square
- % coverage: 100%
- Type of wrap if used: Elastoplast elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: after 4 hours
SCORING SYSTEM:
Erythema and escher formation:
No erythema: 0
Very slight erythema: 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema to slight eschar formation: 4
Oedema formation:
No odema: 0
Very slight oedema: 1
Slight oedema: 2
Moderate oedema: 3
Severe oedema: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 168 hours
- Remarks on result:
- other: For the 100% pure test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.16
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 168 hours
- Remarks on result:
- other: For the 100% pure test substance
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 168 hours
- Remarks on result:
- other: For the 50% test substance in DEP
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 168 hours
- Remarks on result:
- other: for the 50% test substance in DEP
- Irritant / corrosive response data:
- One hour after dosing well defined erythema and very slight oedema of the treated skin were observed in all four rabbits. Erythematous reaction was maintained twenty four hours after dosing when slight oedema was apparent in two rabbits and very slight oedema of the skin was maintained by one rabbit. Very slight oedema was apparent in two rabbits and slight oedema was observed in two rabbits at the forty eight and seventy two hour observations, well defined erythema being maintained by all four animals. Irritant reaction had declined within seven days of dosing, one rabbit exhibiting very slight erythema and oedema with slight desquamation and a second animal exhibiting only very slight oedematous reaction.
Well defined erythema of the treated skin was observed in all four rabbits one hour after dosing. Slight oedema was observed in one rabbit and very slight oedema was apparent in three rabbits at this time. Oedematous reaction had increased twenty four hours after dosing, slight oedema of the skin being observed in three rabbits and very slight oedema of the skin present in one rabbit. Well defined erythema was maintained by all four rabbits at the forty eight hour observation when moderate oedema of the skin was observed in two animals and slight oedematous reaction was noted in the remaining two animals of the group. Oedema of the skin showed slight decline in one rabbit within seventy two hours. Seven days after dosing well defined erythema and oedema were apparent in the remaining rabbit of the group. Desquamation from the surface of the treated skin was also observed in three of the four rabbits. - Other effects:
- None
Any other information on results incl. tables
Mean scores
24-72 hours |
Erythema |
Oedema |
24 hours |
2 |
1.25 |
48 hours |
2 |
1.5 |
72 hours |
2 |
1.5 |
24-72 hours |
Erythema |
Oedema |
24 hours |
2 |
1.75 |
48 hours |
2 |
2.5 |
72 hours |
2 |
2.25 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Hexyl salicylate was found to be a moderate skin irritant under the conditions of this study. The mean scores for skin irritation do not trigger classification as a skin irritant; however as the reactions were not reversible within the study period, classification is appropriate.
- Executive summary:
The irritation potential of hexyl salicylate was tested in a study by Haynes (1986), after exposure for 4 hours under semi-occlusive conditions in the rabbit, both as 100% and as 50% in DEP. The mean score for erythema over the 24-72 hour period was 2.0 for the 100% pure substance. The mean score for oedema over the 24-72 hour period was 2.16 for the 100% pure substance. Hexyl salicylate was found to be a moderate skin irritant under the conditions of this study. The mean scores for skin irritation do not trigger classification as a skin irritant; however as the reactions were not reversible within the study period, classification is appropriate.
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