Registration Dossier
Registration Dossier
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EC number: 203-960-0 | CAS number: 112-33-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only secondary source but quoted as OECD guideline study under GLP.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 2-(2-aminoethoxy)ethanol
- EC Number:
- 213-195-4
- EC Name:
- 2-(2-aminoethoxy)ethanol
- Cas Number:
- 929-06-6
- IUPAC Name:
- 2-(2-aminoethoxy)ethanol
- Details on test material:
- - Name of test material (as cited in study report): 2-(2-aminoethoxy)ethanol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 %
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 %
- No. of animals per dose:
- test group: 20
pos. control: 5
neg control: 10 - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.3. No with. + reactions: 5.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Primary challenges were carried out after 14 days, 1 positive response was observed after 24 and 48 hours in the 10% DGA group. 7 days after the primary challenge, all test article treated animals were rechallenged at 10% concentration. 2 positive responses were observed after 24 and 48 hours after this rechallenge. After initial challenge a positive response was observed in all animals receiving the DNCB positive control. Erythema observed at 24 and 48 hours in 3 of negative control group at initial challenge.
Under EU
criteria, the product is not classed as a sensitizer as it indicates a
maximum (at rechallenge) of 10% positive (2/20) responses. A minimum
figure of 15% under any study would be necessary for classification as a
sensitizer with R43 under EU 18th ATP of the DSD. Practical experience
over 20 years of manufacturing this product adds weight to this
conclusion.
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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