Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02/08/1991-28/11/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to the OECD Guideline and in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine
- Molecular formula:
- R-O-(CH2CH2O)nCH2CO-NH-CH2CH2OH
- IUPAC Name:
- Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine
- Test material form:
- liquid
- Details on test material:
- - Physical state: clear yellow liquid
- Storage conditions: between 20-30°C in the dark
- Stability under test conditions: stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 17 weeks
- Weight at study initiation: 2856-2986 g
- Housing: Individually in labelled cages, with perforated floors and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands), approx.100 gram per day.
- Water (e.g. ad libitum): free access to tap water diluted with decalcified water.
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Body weight: Day 1 of test (application day)
Irritation: Days 1, 2, 3, 4, 8, 15 and 22 - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: test substance was applied to the intact skin using a surgical gauze patch 2 x 3 cm mounted on Micropore tape. The dressing was wrapped around the abdomen and secured with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: the remaining test substance was removed using a tissue moistened with tap water and subsequently a dry tissue.
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : approx 1, 24, 48, 72 hours and 7, 14 and 21 days after the removal of the dressings and test substance
SCORING SYSTEM:
Erythema and eschar formation
No erythema: 0
Very slight erythem: 1
Well-defined erythema:2
Moderate to severe erythema: 3
Severe erythema to slight eschar formation: 4
Oedema formation
No oedema: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:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- The observed skin irritation consisted of slight eschar formation, fissuring of the skin and severe oedema in all three animals. The skin irritation had not resolved completely within the study period (22 days) in all three animals.
Very slight erythema and very slight oedema were observed in animals No. 689 and 711 and very slight erythema only was observed in animal No. 710 on day 22.
There was no evidence of a corrosive effect on the skin. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
Individual findings:
| time after exposure | Rabbit No. | Erythema | Oedema | Comments |
| 45 min | 689 | 2 | 2 | - |
| 710 | 2 | 1 | - | |
| 711 | 2 | 2 | - | |
| 24h | 689 | 2 | 3 | - |
| 710 | 1 | 3 | - | |
| 711 | 2 | 3 | - | |
| 48h | 689 | 4 | 4 | The treated skin showed less elasticity. |
| 710 | 3 | 4 | - | |
| 711 | 4 | 4 | - | |
| 72h | 689 | 4 | 4 | Treated area showed fissuring of the skin and slight eschar formation. |
| 710 | 4 | 4 | Treated area showed fissuring of the skin and slight eschar formation. | |
| 711 | 4 | 4 | The treated skin showed less elasticity. | |
| 7 days | 689 | 1 | 1 | The treated area showed new skin formation and was covered with scales. |
| 710 | 4 | 3 | Treated area showed fissuring of the skin and slight eschar formation. The treated skin also showed less elasticity. | |
| 711 | 4 | 3 | Treated area showed fissuring of the skin and slight eschar formation. | |
| 14 days | 689 | 1 | 1 | The treated area showed new skin formation and was covered with scales. |
| 710 | 1 | 1 | Approx. 75% of the treated area showed new skin formation and approx. 25% showed scaliness. | |
| 711 | 1 | 1 | Approx. 75% of the treated area showed new skin formation and approx. 25% showed scaliness. | |
| 21 days | 689 | 1 | 1 | - |
| 710 | 1 | 0 | - | |
| 711 | 1 | 1 | - |
Note: The observed skin irritation was noted on a skin area covering approximately 6 x 4 cm, due to spreading of the test substace during exposure.
Calculations for EEC Classification:
| Rabbit No. 689 | Rabbit No. 710 | Rabbit No. 711 | ||||
| observation time | Erythema | Oedema | Erythema | Oedema | Erythema | Oedema |
| 24 h | 2 | 3 | 1 | 3 | 2 | 3 |
| 48 h | 4 | 4 | 3 | 4 | 4 | 4 |
| 72 h | 4 | 4 | 4 | 4 | 4 | 4 |
| mean value | 3.3 | 3.7 | 2.7 | 3.7 | 3.3 | 3.7 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the test conditions, test material is classified as H315 "Causes Skin Irritation" Category 2 according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of test material was applied on the clipped skin of the dorsal flank area of 3 female New Zealand rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours, followed by seven observations at approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after removal of dressings and remaining test substance.
The observed skin irritation consisted of slight eschar formation, fissuring of the skin and severe oedema in all three animals. The skin irritation had not resolved completely within the study period (22 days) in all three animals.
Very slight erythema and very slight oedema were observed in animals No. 689 and 711 and very slight erythema only was observed in animal No. 710 on day 22.
There was no evidence of a corrosive effect on the skin.
The individual mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 3.3 / 2.7 / 3.3 for erythema and 3.7 / 3.7 / 3.7 for oedema.
Under the test conditions, test material is classified as H315 "Causes Skin Irritation" Category 2 according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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.
