Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 943-149-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: HLD protocol number P 2/152, revision 5. to meet the requirements of the US Food and Drug Administration as described in the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1995).
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The test item was topically applied under occlusive dressing to intact and abraded skin sites on the back of rabbits once only for a contact period of 24 hours.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
- Molecular formula:
- Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.
- IUPAC Name:
- Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, D-4540 Lengerich
- Age at study initiation: between 11 and 17 weeks
- Weight at study initiation: between 2.78 and 3.38 kg
- Housing: single housing in steel grid floor cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23°C
- Humidity (%): 40 - 70 %
- Air changes (per hr):at least 10 air chamges per hour
- Photoperiod (hrs dark / hrs light): 12 /12 hours
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 25 % in water
TEST SITE: Intact and abraded skin - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 25 hours and 72 hours after treatment
- Number of animals:
- 6 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: about 2.5 x 2.5 cm
- Type of wrap if used: unabraded and abraded skin sites were covered with gauze pads which were the occluded and secured using a strip of impermeable adhesive plastic dressing wrapped around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped but not rinsed with a disposable paper towel
Reactions were scored according to the Draize scale.
SCORING SYSTEM:
Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (deep redness): 4
Oedema formation:
- No oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well-defined by definite raising): 2
- Moderate oedema (raised approx. 1 mm): 3
- Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.33
- Max. score:
- 8
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study, Grilloten PSE 141 G (25% in water). was established to be not irritating to the skin.
According to the criteria of OECD GHS, Regluation (EC) 1272/2008 and of DSD (Directive 67/548/EEC), and no classification and labelling is required. - Executive summary:
In a primary dermal irritation study 6 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of Grilloten PSE 141 G (25 % in water) for 24 hours to 2.5 x 2.5 cm of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.
The study is comparable to a guideline study (OECD 404) with some minor deviations (exposure time 24 h, readings at 24 and 72 h), which do not influence the results of the study.
The test material produced minimal irritation in 3/6 rabbits at the intact sites of five rabbits and abraded site at the 24 hours reading. The reactions had ameliorated completely in all three rabbits by the 72 hours observation.
The test item is considered to be non-irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
