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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 925-653-7 | CAS number: -
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct. 2, 1990- Oct. 23, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Oct. 2, 1990- Oct. 23, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 2
- Reversibility:
- other: 21 days
- Remarks on result:
- other: Fully reversible in all but 2 animals (very minor redness observed)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- All animals showed very slight erythema/eschar at the 3-4 hrs observation. This persisted in all animals until at least day 10, with some animals showing an increase to a score of 2. The erythema/eschar did not resolve in two of the animals by the end of the experiment at day 21. Two animals showed very slight edema at the .75 hr observation, with all animals showing this at the 24 hr observation. The edema symptoms did not worsen, and resolved in all animals by day 21.
- Other effects:
- No other effects were seen in any animal at any observation.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
This data is being read across from the source study that tested C9-C14 aliphatic solvents (2-25% aromatics) based on analogue read across.
This study examined the skin irritancy of MR Solvent to rabbit skin. 3 male and 3 female rabbits were exposed dermally to 0.5 ml of test substance for 4 hrs. Test substance was applied to a clipped dorsal area and the area occluded. After 4 hrs, the test areas were washed with tap water. Once the test substance was removed, the animals were scored for skin irritation. Additional observations were made at 24, 48, and 72 hrs, and 7, 10, 14, 17, and 21 days after removal. Animals exhibited very slight erythema and edema (score of 1) beginning at the first observation. By the 24 hr observation, some of the erythema scores had risen to 2, which reversed by day 10. All edema symptoms had resolved by day 21, however, two animals still had very slight redness on day 21. No other signs of skin irritation were seen. The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Animal |
Observation |
|||||||||
Hours |
Days |
|||||||||
3-4 |
24 |
48 |
72 |
7 |
10 |
14 |
17 |
21 |
||
9918-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9920-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9922-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9913-F |
Erythema/eschar |
1 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9915-F |
Erythema/eschar |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9917-F |
Erythema/eschar |
1 |
1 |
1 |
2 |
2 |
2 |
1 |
1 |
1 |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
|
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week
IN-LIFE DATES: From: Oct. 2, 1990 To: Oct. 23, 1990
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control area on each test animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml undiluted - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 21 days
- Number of animals:
- 6 - 3 males, 3 females
- Details on study design:
- TEST SITE
- Area of exposure: An 8 x 8 cm dorsal area of the trunk was clipped. Part of this area was used as a control.
- % coverage: An approximately 2.5 x 2.5 cm area of the trunk was covered.
- Type of wrap if used: Test material was placed beneath two single layers of surgical gauze which were secured with non-irritating adhesive tape. Trunks of the animals were wrapped with semi-permeable dressing held in place with non-irritating adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with room temperature tap water and wiped with a wet cloth.
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 2
- Reversibility:
- other: 21 days
- Remarks on result:
- other: Fully reversible in all but 2 animals (very minor redness observed)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- All animals showed very slight erythema/eschar at the 3-4 hrs observation. This persisted in all animals until at least day 10, with some animals showing an increase to a score of 2. The erythema/eschar did not resolve in two of the animals by the end of the experiment at day 21. Two animals showed very slight edema at the .75 hr observation, with all animals showing this at the 24 hr observation. The edema symptoms did not worsen, and resolved in all animals by day 21.
- Other effects:
- No other effects were seen in any animal at any observation.
Any other information on results incl. tables
Animal |
Observation |
|||||||||
Hours |
Days |
|||||||||
3-4 |
24 |
48 |
72 |
7 |
10 |
14 |
17 |
21 |
||
9918-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9920-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9922-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9913-F |
Erythema/eschar |
1 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9915-F |
Erythema/eschar |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9917-F |
Erythema/eschar |
1 |
1 |
1 |
2 |
2 |
2 |
1 |
1 |
1 |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
This study examined the skin irritancy of MR Solvent to rabbit skin. 3 male and 3 female rabbits were exposed dermally to 0.5 ml of test substance for 4 hrs. Test substance was applied to a clipped dorsal area and the area occluded. After 4 hrs, the test areas were washed with tap water. Once the test substance was removed, the animals were scored for skin irritation. Additional observations were made at 24, 48, and 72 hrs, and 7, 10, 14, 17, and 21 days after removal. Animals exhibited very slight erythema and edema (score of 1) beginning at the first observation. By the 24 hr observation, some of the erythema scores had risen to 2, which reversed by day 10. All edema symptoms had resolved by day 21, however, two animals still had very slight redness on day 21. No other signs of skin irritation were seen. The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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.
