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Description of key information

Skin sensitization: Product Safety Labs, EPA Guinea Pig Sensitization (Buhler), 1988;Guideline EPA 40 CFR Part 158; Guinea Pigs, 6 % of DMAE in water - not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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.
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
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
6%
Route:
epicutaneous, occlusive
Vehicle:
water
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
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.
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..
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Experimental results of the key GLP- study demonstrate that the test substance is not sensitising. DMAE was applied epicutan to the guinea pigs (Buhler Test). After challenge exposure there were no signs of sensitization. Leung and Blaszcak confirmed this finding, applying 5 % of the test substance to the guinea pigs skin. The substance showed no clear skin responses suggestive of sensitisation. No allergic contact dermatitis was induced.

Justification for classification or non-classification

Due to negative outcomes in guinea pigs in Buhler Test and in Guinea Pig Maximization Test performed with DMAE, classification is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.