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EC number: 216-653-1 | CAS number: 1634-04-4
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Irritation / corrosion
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP non-guideline study, published in an industrial toxicology report on MTBE , minor restrictions, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
- Principles of method if other than guideline:
- Dermal sensitization study in guinea pigs: Landsteiner technique
- GLP compliance:
- no
- Type of study:
- other: Dermal sensitization study in guinea pigs: Landsteiner technique
- Justification for non-LLNA method:
- Study conducted pre-dates provision of LLNA guideline.
Test material
- Reference substance name:
- tert-butyl methyl ether
- EC Number:
- 216-653-1
- EC Name:
- tert-butyl methyl ether
- Cas Number:
- 1634-04-4
- Molecular formula:
- C5H12O
- IUPAC Name:
- 2-methoxy-2-methylpropane
- Details on test material:
- ARCO MTBE: 96.2%; commercial MTBE (Huls): 99.1% (not specified which sample was tested).
Batch number: LBI No. 5028
Storage: under refrigeration
Physical state: clear liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Acclimation period: 2 weeks
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: saline
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- other: saline
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 10
- Details on study design:
- Ten guinea pigs were induced with an initial induction of 0.5 ml of a 0.1% MTBE solution in saline. Every second day for the next three weeks, the animals recieved an intradermal injection of 0.1 ml for a total of ten injections.
Fifteen days after the last injection, the guinea pigs received an intracutaneous challenge injection (0.05 ml of 0.1% solution of MTBE) below the sensitisation site.
Skin reactions were evaluated 24 and 48 hours after treatment and scored 0 to 4 for erythema, oedema and colour using the method of Draize.
The test material was judged to be a sensitizer, if the average of the challenge reactions was greater than the average of the sensitizing reactions by at least 25% in the majority of the animals tested. - Challenge controls:
- 0.05 ml of a 1-% solution of 2,4-dinitro-1-chlorobenzene was given to a positive control group of ten guinea pigs.
- Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitro-1-chlorobenzene (DNCB)
Results and discussion
- Positive control results:
- The results show that DNCB treatment produced a three-fold increase in the diameter of the reaction and a marked increase in erythema 24 hours following the challenge injection.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene; challenge: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Observations revealed very slight to well defined erythema throughout the study.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: induction: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene; challenge: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Observations revealed very slight to well defined erythema throughout the study. .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene; challenge: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Observations revealed very slight to well defined erythema throughout the study
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Induction: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene; challenge: 0.05 ml of 1% solution of 2,4-dinitro-1-chlorobenzene. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Observations revealed very slight to well defined erythema throughout the study.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 0.5 ml of 1% MTBE in saline, followed by 9 injections of 0.1 ml 1% MTBE in saline; challenge: 0.05 ml of 1% MTBE in saline
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Observations revealed very slight to well defined erythema with occasional edema throughout the study
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction: 0.5 ml of 1% MTBE in saline, followed by 9 injections of 0.1 ml 1% MTBE in saline; challenge: 0.05 ml of 1% MTBE in saline. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Observations revealed very slight to well defined erythema with occasional edema throughout the study.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.5 ml of 1% MTBE in saline, followed by 9 injections of 0.1 ml 1% MTBE in saline; challenge: 0.05 ml of 1% MTBE in saline
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Observations revealed very welight to well defined erythema with occasional edema throughout the study
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction: 0.5 ml of 1% MTBE in saline, followed by 9 injections of 0.1 ml 1% MTBE in saline; challenge: 0.05 ml of 1% MTBE in saline. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Observations revealed very welight to well defined erythema with occasional edema throughout the study.
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
MTBE treatment produced no significant increase in the response of the challenge injection as compared to the initial sensitizing or inducing injection.
The dose of MTBE used as the initial injection of 0.5 ml of a 0.1% solution did produce a local irritant effect which would indicate that an effective level was used.
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