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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from IUCLID dataset

Data source

Reference
Reference Type:
secondary source
Title:
IUCLID Dataset
Author:
EUROPEAN COMMISSION – European Chemicals Bureau
Year:
2000
Bibliographic source:
IUCLID Dataset- EUROPEAN COMMISSION – European Chemicals Bureau- 18–FEB–2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization study was conducted in guinea pigs for test chemical N-Methyldiethanolamine.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): N-Methyldiethanolamine
- Molecular formula: C5H13NO2
- Molecular weight: 119.163 g/mol
- Substance type: Organic
- Physical state: liquid
-Smiles: N(CCO)(CCO)C
-InChI:1S/C5H13NO2/c1-6(2-4-7)3-5-8/h7-8H,2-5H2,1H3

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
INDUCTION CONCENTRATION:
Intradermal: 5% in Propylene glycol
Topical: 100%
CHALLENGE CONCENTRATION: 100%
RECHALLENGE CONCENTRATION: 50% and 10%
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
INDUCTION CONCENTRATION:
Intradermal: 5% in Propylene glycol
Topical: 100%
CHALLENGE CONCENTRATION: 100%
RECHALLENGE CONCENTRATION: 50% and 10%
No. of animals per dose:
40
Test :20 (10/sex)
Control:20 (5/sex/Challenge)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 intradermal and 1 topical)
- Exposure period: no data
- Test groups:20
- Control group:20
- Site: no data
- Frequency of applications:no data
- Duration: no data
- Concentrations: Intradermal: 5% in Propylene glycol
Topical: 100%


B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: after 14 days of last induction exposure
- Exposure period:no data
- Test groups:20
- Control group:20
- Site:no data
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after the removal of patches

C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: no data
- Exposure period:no data
- Test groups:20
- Control group:20
- Site:no data
- Concentrations: 50% or 10%
- Evaluation (hr after challenge): 24 and 48 hours after the removal of patches
Challenge controls:
Yes concurrent vehicle .
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
CHALLENGE CONCENTRATION: 100%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
Animals exhibited dermal responses and the severity Indices at Challenge was 0.8 out of a maximum Index of 3.0
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: CHALLENGE CONCENTRATION: 100%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: Animals exhibited dermal responses and the severity Indices at Challenge was 0.8 out of a maximum Index of 3.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: irritation control group
Dose level:
CHALLENGE CONCENTRATION: 100%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
All ten irritation control animals exhibited clear dermal responses and the severity Indices at Challenge was 0.8 out of a maximum Index of 3.0.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: irritation control group. Dose level: CHALLENGE CONCENTRATION: 100%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: All ten irritation control animals exhibited clear dermal responses and the severity Indices at Challenge was 0.8 out of a maximum Index of 3.0..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
CHALLENGE CONCENTRATION: 100%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
Animals exhibits dermal responses and the severity Indices at Challenge was 1.8 out of a maximum Index of 3.0
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: CHALLENGE CONCENTRATION: 100%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: Animals exhibits dermal responses and the severity Indices at Challenge was 1.8 out of a maximum Index of 3.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: irritation control group
Dose level:
CHALLENGE CONCENTRATION: 100%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
All ten irritation control animals exhibited clear dermal responses and the severity Indices at Challenge was 1.6 out of a maximum Index of 3.0.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: irritation control group. Dose level: CHALLENGE CONCENTRATION: 100%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: All ten irritation control animals exhibited clear dermal responses and the severity Indices at Challenge was 1.6 out of a maximum Index of 3.0..
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
RECHALLENGE CONCENTRATION: 50% and 10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0.
Remarks on result:
other: see Remark
Remarks:
Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: RECHALLENGE CONCENTRATION: 50% and 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0..
Reading:
rechallenge
Hours after challenge:
24
Group:
other: irritation control group
Dose level:
RECHALLENGE CONCENTRATION: 50% and 10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0.
Remarks on result:
other: see Remark
Remarks:
Reading: rechallenge. . Hours after challenge: 24.0. Group: other: irritation control group. Dose level: RECHALLENGE CONCENTRATION: 50% and 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0..
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
RECHALLENGE CONCENTRATION: 50% and 10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0.
Remarks on result:
other: see Remark
Remarks:
Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: RECHALLENGE CONCENTRATION: 50% and 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0..
Reading:
rechallenge
Hours after challenge:
48
Group:
other: irritation control group
Dose level:
RECHALLENGE CONCENTRATION: 50% and 10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0.
Remarks on result:
other: see Remark
Remarks:
Reading: rechallenge. . Hours after challenge: 48.0. Group: other: irritation control group. Dose level: RECHALLENGE CONCENTRATION: 50% and 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The severity Indices at Re-challenge was 0.0 out of a maximum Index of 3.0..

Any other information on results incl. tables

In order to differentiate dermal reactions produced by irritation from those produced by sensitization, 20 animals (5/sex/Challenge; treated concurrently during Induction with only vehicle or FCA/water emulsion) were subjected to the same Challenge or Re Challenge procedures as the animals which received test material during the Induction exposures.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material N-Methyldiethanolamine (CAS No: 105-59-9) was observed to be not sensitizing on guinea pigs.
Executive summary:

The skin sensitization study of N Methyldiethanolamine (CAS No: 105-59-9) was carried out in 20 guinea pigs by guinea pig maximization test. During induction animals were first induced intradermal with 5% test material in propylene glycol and dermally with 100%.following induction challenge was performed .since results at Challenge were equivocal a Re–Challenge was performed in the same manner as the Challenge, but at concentrations of 50% and 10% N–methyldiethanolamine.In order to differentiate dermal reactions produced by irritation from those produced by sensitization, 20 animals (5/sex/Challenge; treated concurrently during Induction with only vehicle or FCA/water emulsion) were subjected to the same Challenge or Re Challenge procedures as the animals which received test material during the Induction exposures.Fourteen days after the last induction exposure, the Challenge treatment was administered topically at 100%. Eighteen of the 20 animals challenged with 100% N–methyldiethanolamine exhibited clear dermal responses. Index of Sensitization at Challenge to N–methyldiethanolamine was 90%. The Severity Indices at Challenge for the test material group at 24 and 48 hours are 0.8 and 1.8, respectively, compared to 0.8 and 1.6, respectively, for the irritation control group (out of a maximum Index of 3.0). Due to the responses seen in the irritation controls, a Re–Challenge was performed at lower, less irritating concentrations. Animals were re–challenged with both 50% and 10% N–methyldiethanolamine at separate sites. Dermal evaluations were made approximately 24 and 48 hours after the removal of Challenge/Re–Challenge patches. It was observed that the test animals treated with re-challenged dose 50% and 10% N–methyldiethanolamine were free of dermal responses. The Severity indices at Re–Challenge at 24 and 48 hours were both 0.0 for both the test group and the irritation control group.

Hence the test chemical test chemical N-Methyldiethanolamine (CAS No: 105-59-9) can be considered as non-sensitizing to guinea pigs at 50% and 10% concentration.