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EC number: 404-740-9 | CAS number: 115895-09-5
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from October 3rd, 1988 to October 7th, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the Test Guideline B.4 of the EEC Directive 84/449/EEC and OECD guideline N°404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance was applied under occlusive conditions without justification
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance was applied under occlusive conditions without justification
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 404-740-9
- EC Name:
- -
- Cas Number:
- 115895-09-5
- Molecular formula:
- C26H40Cl2O5
- IUPAC Name:
- ethyl 3,5-dichloro-4-{[(hexadecyloxy)carbonyl]oxy}benzoate
- Details on test material:
- A c. 700 g sample of the test substance was received from the sponsor on
September 19, 1988. It consisted of a fine, white powder, designated:
“AF-366”. Just prior to application, the test substance was mixed with
water in a ratio of 1:1, by weight.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as experimental
animals. Age at study initiation: young adult.
The body weight range was 2571—3108 g. The animals were
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front.
Acclimation period : 6 days.
The cages were placed in a room, controlled for light (12 hours light/12 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water were provided ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- 1:1 ratio of test substance and water
- Controls:
- other: not required, the untreated site of the same rabbit served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50%
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: a shaved, 2.5 cm diameter area on the back or flank of the rabbit
- Type of wrap if used: a plastic cup with the test solution (0.5 g test substance, 0.5 g water) was placed on an area of intact skin and fixed to the application site by means of adhesive tape (Leukopor, BDF). The entire trunk of the rabbit was wrapped with self-adhesive gauze (Fixomull, art. No. 2112, BDF, Germany) to hold the cup in place.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was removed from the skin area after exposure ended
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- There were no skin irritation reactions at any time point in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the resuits obtained it is conciuded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Coxumunities, L 257, Volume 26,
16 September 1983), “AF—366” is not irritating or corrosive to skin.
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