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Diss Factsheets

Administrative data

Description of key information

The results of a local lymph node assay in mice exposed to the substance for 3 consecutive days indicates that the substance is a non-sensitiser.

A structurally similar substance was non-sensitising in a relaible guinea pig maximisation test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 January 2016 - 08 March 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA/Ca
Remarks:
CBA/CaOlaHsd
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10%, 25% or 50%.
No. of animals per dose:
Five/dose
Positive control substance(s):
not specified
Statistics:
The data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. individual and group means disintegrations per minute values were assessed for dose response relationships. Data was first assessed for suitability by analysis of normality and homogeneity of variance. If the asseumptions that the data are both normally distributed and has homogeneity of variances, then parametric one way analysis of variance (ANOVA) and Dunnett's multiple comparison procedure were used to determine statistical significance. If the assumptions were not met, non-parametric Kruskal-Wallis Rank Sum and Mann-Whitney U test procedures were used.

Probability values (p) are presented as follows:
P<0.001 ***
P<0.01 **
P<0.05 *
P>/=0.05 (not significant)
Parameter:
SI
Value:
1.21
Test group / Remarks:
10%
Parameter:
SI
Value:
2.01
Test group / Remarks:
25% in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
2.46
Test group / Remarks:
50% in acetone/olive oil 4:1

 Concentration (%w/w) in acetone/olive oil 4:1  Stimulation Index  Result
 10  1.21  Negative
 25  2.01  Negative
 50  2.46  Negative
Interpretation of results:
GHS criteria not met
Conclusions:
The substance was considered to be a non-sensitiser under the conditions of the test.
Executive summary:

In a local lymph node assay to evaluate the sensitisation potential of the substance female mice (five animals/concentration) were exposed to the substance for 3 consecutive days. The SI of 2.46 (at the highest concentration) indicates that the test material is not a sensitiser.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Read-across to K1 study therefore K2 is the maximum Klimisch value.
Justification for type of information:
Read-across approach - see read-across justification in section 13.
Reason / purpose for cross-reference:
read-across source
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted prior to LLNA being accepted as a TG.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS Albino Dunkin Hartley Guinea Pig, CRL:(HA)BR, SPF (Specific Pathogen Free)
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 538-704 g
- Housing:Individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard guinea pig breeding / maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland) ad lib.
-Water (e.g. ad libitum):Community tap water ad lib.
- Acclimation period: under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2008-11-12 to 2008-12-09
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
5% for intradermal induction, 100% for epidermal induction;
75% for epidermal challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% for intradermal induction, 100% for epidermal induction;
75% for epidermal challenge
No. of animals per dose:
10 control animals and 20 test animals
Details on study design:
RANGE FINDING TESTS:
Intradermal pretest (together with Freund's) in two animals, 75-50-25-15-10 and 5 %. Dermal reactions were assessed 24 hours later based on the results, the test item concentration of 5 % (w/w) was selected for intradermal induction in the main study.
Epidermal pretest (after Freund's) in two animals, 100-75-50 and 25 %. Based on the results, the test item concentration of 75 % (w/w) was selected for epidermal challenge and 100% as lowest irritating concentration for epidermal induction.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x intradermal, 1 x epicutaneous
- Exposure period: intradermal-continuous, epicutaneous: 48 h
Test group:
intradermal induction:
in parallel intradermal injection of Freund's complete adjuvant, test item (5% ) in purified water, Freund's/test item (5%) 1:1
epidermal induction:
100% test item, occlusive conditions, 48 h
- Control group:
intradermal induction:
in parallel intradermal injection of Freund's complete adjuvant, purified water, Freund's/purified 1:1
epidermal induction:
purified water, occlusive conditions, 48 h
- Site: dorsal skin from the scapular region (intradermal and epicutaneous)
- Frequency of applications: once



B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: test item (75%) / water
- Control group: test item (75%) / water
- Site: left flank
- Evaluation (hr after challenge): 24 h, after depilation
Challenge controls:
No re-challenge
Positive control substance(s):
yes
Remarks:
Alpha-Hexylcinnamaldehyde
Positive control results:
90% of positive responders in test group, 0% in control group
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
purified water only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
purified water only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the test group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the test group
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
purified water only
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
purified water only
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group..
Interpretation of results:
GHS criteria not met
Conclusions:
No skin sensitizing potential was identified in the guinea pig Maximization-test with the substance.
Executive summary:

The skin sensitizing potential of the substance was investigated in a guinea pig maximisation test according to OECD 406. Male guinea pigs were treated intradermally (together with Freund's adjuvant) and epicutaneously (lowest irritating concentration) with the test item. Twenty one days after first administration, the substance was applied epicutaneously at the highest non-irritating concentration. The local reactions recorded in the eight test animals (40 %) after the challenge were considered to be of irritant nature. This interpretation is supported by the fact that the reactions faded at the 48-hour reading and that 60 % of the control animals also showed a local erythema at the 24 -hour reading. Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, the substance does not have to be classified and labelled as a skin sensitizer.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings of a local lymph node assay conducted on the substance in mice and a guinea pig maximisation test conducted on a structurally similar substance, classification of the substance is not justified.