Registration Dossier
Registration Dossier
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EC number: 402-950-5 | CAS number: 87826-41-3 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-03-17 to 1988-03-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was carried out to generally valid and internally-accepted guidelines and performed according to GLP.
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 (incl. QA statement)
Test material
- Reference substance name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
- EC Number:
- 402-950-5
- EC Name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
- Cas Number:
- 87826-41-3
- Molecular formula:
- C22 H26 O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-methylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- - Names of test material (as cited in study report): Technical (Production) Gel-All-MD, Dimethylbenzylidene sorbitol
- Substance type: White powder
- Physical state: Solid
- Analytical purity: 98.6% w/w
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: 1988-01-26 to 1988-01-27
- Batch No: 4140626
- Expiration date of the batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Stored in the dark at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gorseside Rabbits, Northchurch, Berkhamstead, Hertfordshire
- Age at study initiation: 12 weeks
- Weight at study initiation: approx 2.0 kg
- Housing: Individually housed in grid-bottomed metal cages.
- Diet: SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex, ad libitum (antibiotic free)
- Water: mains drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 20°C.
- Humidity: 44-77%.
- Air changes (per hr): No data
- Photoperiod: 12 hrs dark / 12 hrs light (fluorescent lighting)
IN-LIFE DATES: No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- (distilled)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g material mixed with 0.5 ml distilled water
VEHICLE
- distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days (observations at 1 hr, 24 hr, 48 hr, 72 hr, 7 days)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: lint pad; held in place with 7.5 cm width elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: With cotton wool soaked in water warmed to approx. 37 °C.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the assessment of colour) and irritation allocated a numerical value based on the following:
Erythema and Eschar formation:
0 - No erythema:
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well defined by definite raising)
3 - Moderate oedema (raised approximately 1mm)
4 - Severe oedema (raised more than 1mm and extending beyond area of exposure)
Other signs of reaction to treatment such as systematic effects were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 769
- Time point:
- other: mean of scores at 24, 48 & 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 773
- Time point:
- other: mean of scores at 24, 48 & 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 774
- Time point:
- other: mean of scores at 24, 48 & 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- animal: 769
- Time point:
- other: mean of scores at 24, 48 & 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- animal: 773
- Time point:
- other: mean of scores at 24, 48 & 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- animal: 774
- Time point:
- other: mean of scores at 24, 48 & 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritant / corrosive response data:
- No irritation or corrosion to any test animal was recorded at any time.
- Other effects:
- No other local or systemic effects.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No irritation was apparent in any animal during the course of the study. It is concluded that Gel All MD is not an irritant to rabbit skin.
- Executive summary:
The purpose of the study was to assess the skin irritation potential of Gel All MD in rabbits.
The method used was designed to meet the requirements of OECD Guideline No. 404.
Gel All MD, moistened with water, was applied for four hours under a semi-occlusive dressing to the clipped dorsal skin of three rabbits. Assessments for skin irritation were made 1, 24, 48 and 72 hours and 7 days after removal of the dressing.
No skin irritation was observed in animal animal at any assessment.
It was concluded that Gel All MD is not irritant to rabbit skin.
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