Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated 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:
other: Only secondary source but quoted as OECD guideline study under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Route:
other: no data
Vehicle:
other: ethanol
Concentration / amount:
10 %
Route:
other: no data
Vehicle:
other: ethanol
Concentration / amount:
10 %
No. of animals per dose:
test group: 20
pos. control: 5
neg control: 10
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene (DNCB)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.3. No with. + reactions: 5.0. Total no. in groups: 5.0.

Primary challenges were carried out after 14 days, 1 positive response was observed after 24 and 48 hours in the 10% DGA group. 7 days after the primary challenge, all test article treated animals were rechallenged at 10% concentration. 2 positive responses were observed after 24 and 48 hours after this rechallenge. After initial challenge a positive response was observed in all animals receiving the DNCB positive control. Erythema observed at 24 and 48 hours in 3 of negative control group at initial challenge.

Under EU criteria, the product is not classed as a sensitizer as it indicates a maximum (at rechallenge) of 10% positive (2/20) responses. A minimum figure of 15% under any study would be necessary for classification as a sensitizer with R43 under EU 18th ATP of the DSD. Practical experience over 20 years of manufacturing this product adds weight to this conclusion.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A validated QSAR model was used to predict the skin sensitising properties of [2 -(2 -dimethylamino)ethoxy)ethanol DMEE by application of the OECD toolbox V3.4. The formation of category was performed by the present organic functional groups of DMEE, thus obtaining a category of various aminoalcohols. These substances are known to have low binding affinity to proteins and therefore no tendency to elicit a immunological response. In conclusion the model predicts that DMEE is not skin sensitising.


A guideline skin sensitisation study (OECD 406) is available for a similar substance [2-(2-aminoethoxy)ethanol] to the test substance. The substance was not considered a skin sensitiser under the conditions of the study and thus the structurally similar substance, DMEE, is not considered to be a skin sensitiser. Practical experience over 20 years of manufacturing DMEE adds weight to this conclusion. The negative result is supported by the

validated QSAR model for DMEE obtained by the OECD toolbox V3.4.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the validated QSAR model (OECD toolbox V3.4.), DMEE is not skin sensitising and do not meet the criteria for classification as a skin sensitizer according to EU Directive 67/548/EEC and Regulation 1272/2008.