2-diethylaminoethanol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to guideline study, not GLP.

Data source

Reference

Reference Type:

publication

Title:

The skin sensitization potential of four alkylalkanolamines

Author:

Leung H-W and Blaszcak DL

Year:

1998

Bibliographic source:

Vet. Hum. Toxicol. 40(2): 65-67.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

according to Magnusson, B. and Kligman, A.M.: J. Invest. Derm. 52, 268; the method met the main requirements of OECD Guideline 406.

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Test material information

Constituent 1

Reference substance name:

2-diethylaminoethanol

EC Number:

202-845-2

EC Name:

2-diethylaminoethanol

Cas Number:

100-37-8

Molecular formula:

C6H15NO

IUPAC Name:

2-(diethylamino)ethanol

Details on test material:

- Name of test material (as cited in study report): 2-diethylaminoethanol
- Analytical purity: indicated

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: saline or ethanol

Induction 2

Concentration / amount:

1st application: Induction 5 % intracutaneous2nd application: Induction 25 % occlusive epicutaneous3rd application: Challenge 5 % occlusive epicutaneous

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: saline or ethanol

Challenge 2

Concentration / amount:

1st application: Induction 5 % intracutaneous2nd application: Induction 25 % occlusive epicutaneous3rd application: Challenge 5 % occlusive epicutaneous

No. of animals per dose:

20

Details on study design:

For induction, the animals were given intradermal injections into 2 sites each of clipped shoulder skin followed by a 48-hour application 7 days later. After removal of the 48-hour patches, the application sites were washed. Epicutaneous challenge was performed by a 24-hour patch at 14 days after epicutaneous induction (i.e. 21 days after beginning of the study); the challenge patch was applied to a previously untreated site. Observation times after challenge were 24 and 48 h after removal of occlusive dressings.  

Challenge controls:

For the positive control, 10 guinea pigs were treated with 1-chloro-2,4-dinitro-benzene (DNCB) using a concentration of 0.1 % for induction (intradermal and topical) and challenge (topical).

Positive control substance(s):

yes

Remarks:

1-chloro-2,4-dinitro-benzene (DNCB)

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5 %

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

All 20 animals challenged with a 5% concentration of the test substance were free of skin responses after 24 and 48 hours following challenge.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: All 20 animals challenged with a 5% concentration of the test substance were free of skin responses after 24 and 48 hours following challenge. .

Results 2

Reading:

1st reading

Hours after challenge:

48

Group:

positive control

Dose level:

0.1%

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

All 10 animals challenged with 0.1% of the positive control DNCB showed clear skin response after 24 and 48 hours following challenge.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: All 10 animals challenged with 0.1% of the positive control DNCB showed clear skin response after 24 and 48 hours following challenge..

Any other information on results incl. tables

None of the animals treated with the test substance (0/20) exhibited skin  responses. All 10 positive control animals challenged 

with 0.1 % DCNB  showed a clear skin response.  Except for one animal which had a score of  1 (meaning weak), all irritation control 

animals were free of skin  responses.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classifiedDSD: not classified