2-dimethylaminoethanol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 July - 10 August 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Older guideline followed but results valid, sufficient documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA 40 CFR Part 158

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

Bühler test with Guinea pigs was performed before the LLNA was set as preferred test method.

Test material

Test material information

Constituent 1

Reference substance name:

2-dimethylaminoethanol

EC Number:

203-542-8

EC Name:

2-dimethylaminoethanol

Cas Number:

108-01-0

Molecular formula:

C4H11NO

IUPAC Name:

2-(dimethylamino)ethanol

Details on test material:

- Name of test material (as cited in study report): 00272 Dimethylaminoethanol
- Molecular formula (if other than submission substance): na
- Molecular weight (if other than submission substance): na
- Smiles notation (if other than submission substance): na
- Substance type: clear liquid
- Physical state: liquid
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Expiration date of the lot/batch: no data

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: no data
- Weight at study initiation: 332 - 451g
- Housing: 5 per cage (stainless steel)
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 24d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66 - 72F
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1 July To: 10 August 1988

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

Concentration / amount:

6%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

6%

No. of animals per dose:

15

Details on study design:

RANGE FINDING TESTS:
2 guinea pigs tested with 50, 25, 12.5 and 6.25 % each. 6% was established as highest non-irritating dose

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6h
- Test groups: 10 induced + 5 naive GPs
- Control group: Positive control 10 induced + 5 naive GPs
- Site: thoracolumbar region
- Frequency of applications: 48h
- Duration: 6h
- Concentrations: 6%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:after 14d
- Exposure period: 6h
- Test groups: 10 induced + 5 naive GPs
- Control group: Positive control 10 induced + 5 naive GPs
- Site: thoracolumbar region, left side
- Concentrations: 6%
- Evaluation (hr after challenge): 24 and 48h

Positive control substance(s):

yes

Remarks:

0.08% DNCB in 95% ethanol

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

other: Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on negative control results.

Group:

negative control

Dose level:

no details given on negative control

Remarks on result:

other: Reading: other:

Remarks:

No details given on negative control. Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on negative control results.

Results 2

Reading:

other: Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period.

Group:

test chemical

Dose level:

no details given

Remarks on result:

other: Reading: other:

Remarks:

Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period..

Results 3

Reading:

other: Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on positive control results.

Group:

positive control

Dose level:

no details given on positive control

Remarks on result:

other: Reading: other:

Remarks:

No details given on positive control. Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on positive control results.

Any other information on results incl. tables

Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in destilled water) over a 3 1/2 week induction period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in destilled water) over a 3 1/2 week induction period.

Executive summary:

DMAE was tested on skin sensitization potential in guinea pigs. The test substance did not cause sensitization after challenge exposure.