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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

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)
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethoxy-2-methylpropane
EC Number:
211-309-7
EC Name:
2-ethoxy-2-methylpropane
Cas Number:
637-92-3
Molecular formula:
C6H14O
IUPAC Name:
2-ethoxy-2-methylpropane
Details on test material:
- Name of test material (as cited in study report): ETBE
- Physical state: colourless liquid
- Analytical purity: 95.8%
- Lot/batch No.: 93050601

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: about 6 weeks
- Weight at study initiation: 250 -550 gram
- Housing:group-housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +- 3
- Humidity (%): >45
- Air changes (per hr): >22
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sterile liquid paraffin
Concentration / amount:
10% induction; 100% challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sterile liquid paraffin
Concentration / amount:
10% induction; 100% challenge
No. of animals per dose:
10 male + 10 female in the test group
5 male + 5 female in the control group
Details on study design:
INDUCTION:
- intradermal injection:

- 50% Freund's complete adjuvant (2 x 0.1 ml)
- 10% v/v ETBE in sterile liquid paraffin (2 x 0.1 ml)
- 10% v/v ETBE in 50% Freund's complete adjuvant (2 x 0.1 ml)

The control animals received sterile liquid paraffin (2 x 0.1 ml), also by intradermal injection.

- topical occlusive application (for 48 hours): 0.5 ml undiluted ETBE was applied to the injection site (under occlusion) after treating the skin with 10% SLS. The control animals received sterile liquid paraffin in place of ETBE.

CHALLENGE:

0.5 ml undiluted ETBE was applied to a 2 x 2 cm area of clipped and depilated skin on the left flank of each control and test animal (for 24 hours). Skin responses were recorded at 24 and 48 hr post-challenge.
Challenge controls:
The control group was exposed to the vehicle, sterile liquid paraffin, only.
Positive control substance(s):
no

Results and discussion

Positive control results:
No positive control was tested.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction: 3 series of 2 x 0.1 ml injections of Freund's complete adjuvant, ETBE (10% solution in paraffin) and mixture 50/50 of ETBE (20% in paraffin) and Freund's complete adjuvant; followed by 0.5 ml ETBE topically for 48 hr; challenge: 0,5 ml ETBE
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
The macroscopic examinations did not reveal any lesions of delayed hypersensitivity
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction: 3 series of 2 x 0.1 ml injections of Freund's complete adjuvant, ETBE (10% solution in paraffin) and mixture 50/50 of ETBE (20% in paraffin) and Freund's complete adjuvant; followed by 0.5 ml ETBE topically for 48 hr; challenge: 0,5 ml ETBE. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: The macroscopic examinations did not reveal any lesions of delayed hypersensitivity.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction: 3 series of 2 x 0.1 ml injections of Freund's complete adjuvant, ETBE (10% solution in paraffin) and mixture 50/50 of ETBE (20% in paraffin) and Freund's complete adjuvant; followed by 0.5 ml ETBE topically for 48 hr; challenge: 0,5 ml ETBE
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
The macroscopic examinations did not reveal any lesions of delayed hypersensitivity
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction: 3 series of 2 x 0.1 ml injections of Freund's complete adjuvant, ETBE (10% solution in paraffin) and mixture 50/50 of ETBE (20% in paraffin) and Freund's complete adjuvant; followed by 0.5 ml ETBE topically for 48 hr; challenge: 0,5 ml ETBE. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: The macroscopic examinations did not reveal any lesions of delayed hypersensitivity.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 3 series of 2 x 0.1 ml injection of Freund's complete adjuvant, liquid paraffin and mixture 50/50 liquid paraffin and Freund's complete adjuvant; followed by 0.5 ml liquid paraffin for 48 hr topically; challenge: 0.5 ml ETBE
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No cutaneous abnormality was noted in the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 3 series of 2 x 0.1 ml injection of Freund's complete adjuvant, liquid paraffin and mixture 50/50 liquid paraffin and Freund's complete adjuvant; followed by 0.5 ml liquid paraffin for 48 hr topically; challenge: 0.5 ml ETBE. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No cutaneous abnormality was noted in the control group.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 3 series of 2 x 0.1 ml injection of Freund's complete adjuvant, liquid paraffin and mixture 50/50 liquid paraffin and Freund's complete adjuvant; followed by 0.5 ml liquid paraffin for 48 hr topically; challenge: 0.5 ml ETBE
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No cutaneous abnormality was noted in the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 3 series of 2 x 0.1 ml injection of Freund's complete adjuvant, liquid paraffin and mixture 50/50 liquid paraffin and Freund's complete adjuvant; followed by 0.5 ml liquid paraffin for 48 hr topically; challenge: 0.5 ml ETBE. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No cutaneous abnormality was noted in the control group.

Any other information on results incl. tables

Visual examination of the challenge site revealed no evidence of any redness or oedema in any of the control or test animals (all scores = 0). Under the conditions of the test, ETBE did not provoke any sign of cutaneous sensitisation in the guinea pig.

Applicant's summary and conclusion