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Diss Factsheets

Administrative data

Description of key information

Sensitisation

In a Delayed Contact Hypersensitivity Study in Guinea Pigs the test material was not found to be a skin sensitizer. It may be predicted from this that (analogue read-across) the registered substance would share a similar toxicity profile and would also not be predicted to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to Buehler protocol which satisfies the citeria of toxic control act (40 CFR) and the OECD Guideline, GLP, well documented
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Conducted to general conditions satisfying the OECD Guideline
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was conducted in 1990 before the requirement to use the LLNA became mandatory.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: approved supplier
- Weight: 374-623g
- Housing: wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum, PURINA GUINEA PIG CHOW
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least four days


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h each
Route:
epicutaneous, occlusive
Vehicle:
other: 80/20 ethanol/dest water; acetone
Concentration / amount:
Pilot: 100% (without vehicle), 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% (partly in 80/20 ethanol/dest water)
Main study Induction: 5% (in 80/20 ethanol/dest water)
Challenge: 2.5% (in acetone)
Route:
epicutaneous, occlusive
Vehicle:
other: 80/20 ethanol/dest water; acetone
Concentration / amount:
Pilot: 100% (without vehicle), 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% (partly in 80/20 ethanol/dest water)
Main study Induction: 5% (in 80/20 ethanol/dest water)
Challenge: 2.5% (in acetone)
No. of animals per dose:
Main study test group: 10 males and 10 females
Main study control group: 5 males and 5 females
Details on study design:
RANGE FINDING TESTS:
Primary irritation 8 male and 8 female animals were used.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Frequency of applications: once a week
- Concentrations: 5%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction exposure
- Exposure period: 6h
- Test groups: 10 animals per gender
- Control group: 5 animals per gender
- Concentrations: 2.5%
- Evaluation (hr after challenge): 24hr
Challenge controls:
5 animals per gender were used as control, no positive control is reported
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Only grade ± reactions comparable to the controls were observed. The test substance is considered not to be a skin sensitizer..
Executive summary:

The potential of the test item, as a 5% w/v formulation in 80% ethanol/20% distilled water, to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler.

Following primary challenge, there were no grades of 1 produced in the test or control animals. The incidence of grade + responses in the test group (14 of 20) was compared to that of the naive control group (7 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitization had not been induced.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across hypothesis proposed is that the organism is not exposed to common compounds but rather, as a result of structural similarity, that different compounds have similar toxicological and fate properties. In this case the ECHA Read-Across Assessment Framework (RAAF) Scenario 2 is used.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: N,N-Dimethyldecan-1-amide, mixture with N,N-Dimethyloctanc-1-amide [CAS 67359-57-3]
Target: Reaction Mass of N,N-Dimethyldodecanamide and N,N-Dimethyltetradecanamide [EC not assigned; CAS not assigned]

3. ANALOGUE APPROACH JUSTIFICATION
It may be concluded that both the registered substance (target) and the source molecules can be regarded as close structural analogues having both similar physical chemical and toxicological properties. It follows that where endpoints for the registered substance may not have experimental evidence, particularly those involving animal studies, that these can be addressed by read across grouping using an analogue approach. It is therefore proposed that, after careful assessment, experimental data from the source molecules may be used as surrogate evidence for read across to the registered substance. Please refer to attached document for information on the data available to support the read-across.

4. DATA MATRIX
Please refer to attached document
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Group:
positive control
Remarks on result:
not measured/tested
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No studies are available which investigate the skin sensitising potential of Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide. Data are available from an analogue.

A test with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyldodecanamide and N,N-dimethylhexanamide) for skin sensitisation was done using an adaptation of the method of Ritz and Buehler* (Stepan 1990, J.J Kreuzmann).The test substance was used as 5% w/v formulation in 80% ethanol/20% distilled water for induction and as 2.5% formulation in acetone for challenge and epicutanueous occlusive applied to 20 guinea pig. There were no grades of 1 produced in the test or control animals. The incidence of grade + responses in the test group (14 of 20) was compared to that of the naive control group (7 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitization had not been induced. Therefore the mixture was classified as not sensitising.

The results of this study are read across to the registered substance, Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide.

* Study according to Buehler protocol which satisfies the criteria of toxic control act (40 CFR) and the OECD Guideline, GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:

Skin sensitisation was not observed in a skin sensitisation guinea pig study (buehler protocol; mixture of dimethylamides): The scores obtained from the study led to no classification for skin sensitisation according to GHS (Regulation (EU) 1272/2008). It may be predicted from this that (analogue read-across) the registered substance,

Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide, would share a similar toxicity profile and would also not be predicted to be a skin sensitiser.

Respiratory sensitisation:

There are no data available to classify Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide as a sensitizer to respiratory system.