Registration Dossier
Registration Dossier
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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.
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