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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- From 1990-08-14 to 1990-11-09
- 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 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
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
- Lot/batch No.: DC 1295.3
- Storage condition of test material: At room temperature, in the dark.
Test animals
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- Intradermal injections: 5% with oleum arachidis
Epidermal applications: 75% in vaseline
Challenge: 25% in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- Intradermal injections: 5% with oleum arachidis
Epidermal applications: 75% in vaseline
Challenge: 25% in vaseline
- No. of animals per dose:
- Control group: 5 males and 5 females
Test group: 10 males and 10 females
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 ml/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 ml/site. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 ml/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1 ml/site. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % in vaseline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % in vaseline. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in vaseline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in vaseline. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % in oleum arachides
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % in oleum arachides. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in oleum arachides
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema/Edema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in oleum arachides. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.
Any other information on results incl. tables
Sensitizing effects
Positive erythema reactions after the first challenge procedure |
||
|
after 24 hours |
after 48 hours |
|
Positive / total |
Positive / total |
Control group |
|
|
ALKYL (C13-C15)- GLYCIOYLETHER |
0 / 10 |
0 / 10 |
vehicle only |
0 / 10 |
0 / 10 |
Test group |
|
|
ALKYL (C13-C15)- GLYCIOYLETHER |
20 / 20 |
20 / 20 |
vehicle only |
0 / 20 |
0 / 20 |
Positive erythema reactions after the second challenge procedure |
||
|
after 24 hours |
after 48 hours |
|
Positive / total |
Positive / total |
Control group |
||
vehicle only |
0 / 10 |
0 / 10 |
Test group |
||
ALKYL (C13-C15)- GLYCIOYLETHER |
17 / 20 |
11 / 20 |
vehicle only |
0 / 20 |
0 / 20 |
Mortality / Viability
No death occurred during the study.
Symptoms, systemic
No systemic symptoms were observed in the animals.
Body weights
The body weight gain of the animals was not affected adversely during the study.
Applicant's summary and conclusion
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