Registration Dossier
Registration Dossier
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: 203-905-0 | CAS number: 111-76-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP guideline study for which the full study report is available. No data on substance purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate guinea pig maximisation study already available.
Test material
- Reference substance name:
- 2-butoxyethanol
- EC Number:
- 203-905-0
- EC Name:
- 2-butoxyethanol
- Cas Number:
- 111-76-2
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-butoxyethanol
- Details on test material:
- - Name of test material (as cited in study report): 2-butoxyethanol
- Physical state: liquid
- Lot/batch No.: S17910T01
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lab colony
- Initial weight: 300-331g
- Diet: RGP pellets, hay, cabbage ad libitum
- Water ad libitum
IN-LIFE DATES: From: 4/12/89 To: 11/1/90
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal injections: 0.5%, epicutaneous induction exposure: 25%, challenge exposure: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal injections: 0.5%, epicutaneous induction exposure: 25%, challenge exposure: 10%
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: Irritation test. Intradermal injections of concentrations in 0.9% saline and occluded patch irritation tests to establish non irritant concentrations. For intradermal injections, concentrations up to 0.5% only produced a faint pinkness. At 1% elevated reaction and/or odema occured. For the occluded patch irritancy test, 10% concentration produced no reaction, whereas 25% produced very faint erythema.
MAIN STUDY- intradermal injection followed one week later by occluded patch application.
A1. INDUCTION EXPOSURE - intradermal
- Site: dorsal shoulder area
- Preparation: clipped
- Concentrations: 0.5% in 0.9% saline, with and without 50% Freund's complete adjuvant. (FCA also injected alone.)
A2. INDUCTION EXPOSURE -occluded patch
- Exposure period: 48 hours
- Site: same 2x4cm dorsal shoulder area as above.
- Concentrations: FIlter paper saturated with 25% 2-butoxyethanol in 0.9% saline held in place with adhesive wrap.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 13 and 20 days after second induction exposure.
- Exposure period: 24 hours
- Site: clipped and shaved flank
- Concentrations: 8mm diameter fileter paper patch in an 11mm dia aluminium test cup saturated with 10% 2-butoxyethanol in 0.9% saline held in place by adhesive plaster.
- Evaluation (hr after challenge): 24, 48hrs - Challenge controls:
- Yes. Controls treated subject to FCA intradermal injection and either first or second 2-butoxyethanol challenge exposure (4 animals for each.)
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Statistics:
- no data
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:
- 2
- Total no. in group:
- 10
- Clinical observations:
- no adverse reactions seen
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: no adverse reactions seen.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- no adverse reactions seen
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: no adverse reactions seen.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no adverse reactions seen
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no adverse reactions seen.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no adverse reactions seen
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no adverse reactions seen.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Substance shows signs of skin irritancy but is not a skin sensitiser.
- Executive summary:
In a GLP study performed according to OECD guideline 406, 2 -butoxyethanol was tested in Guinea Pigs for sensitisation potential . Induction was performed with a dermal injection of 0.5 % 2 -butoxyethanol in 0.9 % saline and a topical application of a 25 % 2 -butoxyethanol in 0.9 % saline. Challenge was made with a topical application of 10 % 2 -butoxyethanol in saline. All topical applications were made occlusively. Concentrations tested were based on results found in preliminary studies (showing a Maximal Concentration with No Irritation (CMNI) of 10 %). Two challenge applications were made at one week interval.
No evidence of sensitisation was seen in treated animals both at challenge and re-challenge.
Synopsis: not sensitising.
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.
