Registration Dossier
Registration Dossier
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EC number: 946-342-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1991 - October 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Elicited via a disturbance of the desquamation process and an inflammatory response (i.e. papules, vesicles, bullae and oedema), skin irritation requires penetration of the stratum corneum and elicitation of a biological response. In accordance with Annex VI, the in vivo acute dermal irritation / corrosion study (OECD 404) was considered sufficient to fulfil the REACH Annex VII information requirement for skin irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl 2-[[(Z)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
- Molecular formula:
- C17H21NO2
- IUPAC Name:
- Methyl 2-[[(Z)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
- Reference substance name:
- Methyl 2-[[(E)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
- Molecular formula:
- C17H21NO2
- IUPAC Name:
- Methyl 2-[[(E)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits
- Remarks:
- Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.6 to 2.8 kg
- Housing: PPL cages (45 x 55 cm) with perforated floor, caged individually
- Diet : ad libitum, feed pellets
- Water: ad libitum, drinking water acidified to pH 2.5 with hydrochloric acid
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): Light was on from 6 to 18 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Ethanol 96% and diethyl phthalate (DEP) in the ratio 1:1 (w/w)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: 100%, 50% (w/w), 25% (w/w), 10% (w/w) and 5% (w/w)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Ethanol 96% and diethyl phthalate (DEP) in the ratio 1:1 (w/w) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal anterior, central and posterior
- % coverage: An area of 10 x 10 cm on the back of each animal was clipped and divided into 6 test sites, each test site with an area of 2.5 x 2.5 cm, with 1 cm between each test site
- Type of wrap if used: Gauze patches, secured with adhesive tape and Scanpor tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with soap and lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS: Skin reactions were assessed 30 min after washing, at 24, 48 and 72 h after application, and at 7 and 14 days after application
SCORING SYSTEM:
- Method of calculation: Erythema and eschar formation and oedema formation were scored from 0 (no effects) to 4 (severe effects). The scores for erythema and oedema formation for the last 3 readings of each rabbit (24, 48 and 72 hours) for each test concentration were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation of the individual rabbit for each test concentration. The mean scores for erythema and oedema formation in the four rabbits used for each concentration tested were subsequently calculated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 100% concentration
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 50% concentration
- Time point:
- 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 25% concentration
- Time point:
- 72 h
- Score:
- 0.9
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 10% concentration
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 5% concentration
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Vehicle
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 100% concentration
- Time point:
- 72 h
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 50% concentration
- Time point:
- 72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 25% concentration
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 10% concentration
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 5% concentration
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Vehicle
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Other effects:
- A dense layer of white scales was observed in all rabbits at the test sites treated with 50% and 100% concentration on days 7 and 14. In one rabbit, a dense layer of white scales was also observed at 25% concentration on day 7, and scattered white scales were observed at 5% and 10% concentration on days 7 and 14 and at 25% concentration on day 14. The appearance of white scales suggests that the treatment may increase transdermal water loss.
Any other information on results incl. tables
Table 1. Mean individual erythema-eschar and oedema values after 72 hours
| Rabbit number | Test concentration | Mean erythema-eschar score | Mean oedema score |
| 1 | Vehicle | 0.00 | 0.00 |
| 1 | 5% | 0.00 | 0.00 |
| 1 | 10% | 1.00 | 0.00 |
| 1 | 25% | 1.33 | 1.00 |
| 1 | 50% | 2.00 | 2.00 |
| 1 | 100% | 2.00 | 2.00 |
| 2 | Vehicle | 1.00 | 0.00 |
| 2 | 5% | 0.00 | 0.00 |
| 2 | 10% | 1.00 | 0.00 |
| 2 | 25% | 0.67 | 0.00 |
| 2 | 50% | 1.00 | 0.00 |
| 2 | 100% | 1.67 | 1.67 |
| 3 | Vehicle | 0.00 | 0.00 |
| 3 | 5% | 0.00 | 0.00 |
| 3 | 10% | 0.67 | 0.00 |
| 3 | 25% | 1.00 | 0.33 |
| 3 | 50% | 1.33 | 0.67 |
| 3 | 100% | 1.67 | 1.33 |
| 4 | Vehicle | 0.00 | 0.00 |
| 4 | 5% | 0.00 | 0.00 |
| 4 | 10% | 0.00 | 0.00 |
| 4 | 25% | 0.67 | 0.00 |
| 4 | 50% | 1.00 | 0.67 |
| 4 | 100% | 1.33 | 0.67 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- For the vehicle and test item at concentrations at 5, 10, 25, 50 and 100% concentration, the mean erythema scores were 0.3, 0.0, 0.7, 0.9, 1.3 and 1.7, respectively, and the mean oedema scores were 0.0, 0.0, 0.0, 0.3, 0.8 and 1.4, respectively. At 72 hours, well-defined erythema was observed at 50-100% test item concentrations, slight erythema was observed at lower concentrations. Slight to barely perceptible oedema was also observed at the high concentrations. All erythema and oedema was reversible, with only flaky skin (white scales) observed during post observation periods, suggesting that treatment may affect transdermal water loss.
- Executive summary:
The skin irritation potential of the test item was assessed in four SPF albino female rabbits, at concentrations of 5, 10, 25, 50 and 100%, in addition to a vehicle control. The back of each rabbit was clipped and divided into 6 test sites, at which 0.5mL of each treatment was applied and secured with a gauze patch. After 4 hours’ exposure, patches were removed and the treated skin was cleaned with soap and water. Skin reactions (erythema and eschar formation and oedema formation) were assessed on a scale from 0 to 4, at 4.5, 24, 48 and 72 hours after application.
For the vehicle and test item at concentrations at 5, 10, 25, 50 and 100% concentration, the mean erythema scores were 0.3, 0.0, 0.7, 0.9, 1.3 and 1.7, respectively, and the mean oedema scores were 0.0, 0.0, 0.0, 0.3, 0.8 and 1.4, respectively. At 72 hours, well-defined erythema was observed at 50-100% test item concentrations, slight erythema was observed at lower concentrations. Slight to barely perceptible oedema was also observed at the high concentrations. All erythema and oedema was reversible, with only flaky skin (white scales) observed during post observation periods, suggesting that treatment may affect transdermal water loss.
Performed according to guidelines OECD 404 and GLP, the study is considered reliable without restriction (Klimisch 1). There is no evidence of an inherent capability to irritate the skin, requiring classification or substance specific risk mitigation measures (RMM).
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