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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 938-925-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 15, 2012 to March 23, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of n-octanol and acrylic acid, first distillation pitch
- EC Number:
- 938-925-5
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Reaction products of n-octanol and acrylic acid, first distillation pitch
- Details on test material:
- - Physical state: Light yellow viscous liquid
- Analytical purity: UVCB
- Expiration date of the lot/batch: May 11, 2013
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Housing: Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands)
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24ºC
- Humidity (%): 40 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after the removal of the dressings and test substance
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm
- Type of wrap if used: Micropore tape
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 (beet redness) *........................................................................................ 4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
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 approximately 1 millimeter) ....................................................................... 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)..... 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 24 hours
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1. Individual skin irritation scores
Animal |
2401 |
246 |
250 |
||||||
Time after exposure |
Erythema (0-4) |
Oedema (0-4) |
comments |
Erythema (0-4) |
Oedema (0-4) |
comments |
Erythema(0-4) |
Oedema (0-4) |
comments |
1 hour |
1 |
1 |
- |
1 |
1 |
- |
1 |
1 |
- |
24 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
48 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
72 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
1Sentinel.
Table 2. Mean value irritation scores
Animal |
Mean 24, 48 and 72 hours |
|
Erythema |
Oedema |
|
240 |
0.0 |
0.0 |
246 |
0.0 |
0.0 |
250 |
0.0 |
0.0 |
Table 3. Animal specifications
Animal |
Sex |
Age at start (weeks) |
Body weighs (grams) |
|
prior to application |
at termination |
|||
240 |
male |
10 |
2289 |
2356 |
246 |
male |
11 |
2508 |
2608 |
250 |
male |
11 |
2453 |
2504 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was found not irritating in the skin of rabbits.
- Executive summary:
The skin irritation of the substance was determinated according to OECD 404 guideline with GLP. The substance was found to be not irritating for the rabbits' skin. Slight irritation was observed in all three animals (both score: oedema and erythema) after four hours with the score 1, this result was fully reversible after 24 hours in all animals.
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.
