Registration Dossier
Registration Dossier
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EC number: 268-358-2 | CAS number: 68081-84-5 This substance is identified by SDA Substance Name: C10-C16 alkyl glycidyl ether and SDA Reporting Number: 15-076-00.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1988-08-01 to 1988-08-05
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Cited from ECHA disseminated dossier Query date: 2015-07-22 For justification of read across please refer to IUCLID section 13.
Data source
Reference
- Reference Type:
- other: ECHA disseminated dossier
- Title:
- No information
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 939-183-5
- EC Number:
- 939-183-5
- IUPAC Name:
- 939-183-5
- Details on test material:
- Name of test material: Alkyl (C13-C15) - glycidylether
Physical state: Liquid
Analytical purity: >99%
Lot/batch No.: DC 1295.3
Stability under test conditions: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 1 male and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Average score: 1.3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Average score: 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Average score: 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Average score: 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Average score: 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Average score: 0.3
Any other information on results incl. tables
Skin irritation scores:
Time period |
Animal |
Sex |
Erythema |
Edema |
Cumulative Score |
Mean Cumulative Score |
1HR |
4 |
M |
1 |
0 |
1 |
1.33 |
5 |
F |
1 |
0 |
1 |
||
6 |
F |
1 |
1 |
2 |
||
24HRS |
4 |
M |
1 |
0 |
1 |
1.33 |
5 |
F |
1 |
0 |
1 |
||
6 |
F |
1 |
1 |
2 |
||
48HRS |
4 |
M |
1 |
0 |
1 |
1 |
5 |
F |
1 |
0 |
1 |
||
6 |
F |
1 |
0 |
1 |
||
72HRS |
4 |
M |
2 |
0 |
2 |
1.33 |
5 |
F |
1 |
0 |
1 |
||
6 |
F |
1 |
0 |
1 |
||
7 DAYS |
4 |
M |
0 |
0 |
0 |
0 |
5 |
F |
0 |
0 |
0 |
||
6 |
F |
0 |
0 |
0 |
Skin irritation: mean scores
Animal |
Sex |
Erythema |
Edema |
Cumulative Score |
Mean Cumulative Score |
4 |
M |
1.33 |
0 |
1.33 |
1.22 |
5 |
F |
1 |
0 |
1 |
|
6 |
F |
1 |
0.33 |
1.33 |
Selected observations for mean scores: 24h, 48h and 72h.
Irritation
Alkyl (C13-C15)-glycidylether showed a primary irritation score of 1.22 when applied undiluted to intact rabbit skin.
Local signs (mean 1 hour to 7 days) consisted if grade 0.87 erythema and grade 0.13 edema.
Coloration
In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.
Body weights
The body weight gain of all rabbits was similar.
Toxic symptoms / mortality
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Necropsy
No necropsy was performed at termination of observation.
Applicant's summary and conclusion
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.
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