Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline 406 and in compliance to GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Available study not conducted specifically for REACH.

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2,4-diaminophenoxy)ethanol dihydrochloride
EC Number:
266-357-1
EC Name:
2-(2,4-diaminophenoxy)ethanol dihydrochloride
Cas Number:
66422-95-5
Molecular formula:
C8H12N2O2.2ClH
IUPAC Name:
2-(2,4-diaminophenoxy)ethan-1-ol dihydrochloride
Details on test material:
Test item : Imexine OAJ
EC number : 266-357-1
Batch number : 0101297
Purity : 99.6%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: ~3 months old
- Weight at study initiation: 347+/-9g for males and 339+/-9g for females
- Housing: Individually in polycarbonate cages (48cm x 27cm x 20cm)
- Diet : Free access to 106 pelleted diet (UAR, Villemoisson-sur-Orge, France)
- Water : Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): 12 cyles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
500 mg undiluted
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
500 mg undiluted
No. of animals per dose:
Number of animals : 15 animals of each sex
Number of control animals : 5 male, 5 female
Number of treated animals : 10 male, 10 female
Details on study design:
The sites to be treated were clipped and/or shaved before each induction or challenge application. The concentration of Imexine OAJ used for challenge and induction applications was selected on the basis of the results of a preliminary irritation test where undiluted Imexine OAJ was non-irritant under the conditions of the study. The induction procedure consisted of 3 weekly topical applications of neat Imexine OAJ. On day 1, a moistened gauze pad (about 4 cm2) dampened with 0.5 ml water or loaded with 500 mg neat Imexine OAJ was applied to the anterior left flank of control (5/sex) or treated (10/sex) animals, respectively. It was held in place for 6 hours by an occlusive dressing. This treatment was repeated on day 8 and day 15 of the study. On day 29, following a 2- week rest period, all control and treated animals received under similar conditions a topical challenge application of 0.5 ml water and 500 mg neat Imexine OAJ on posterior left and right flank, respectively. Cutaneous reactions were assessed 24 hours after each dressing removal during the induction period, and 24, 48 and 72 hours after removing the dressing of challenge application.
Positive control substance(s):
yes
Remarks:
2,4-dinitro-1-chlorobenzene

Results and discussion

Positive control results:
Under the experimental conditions and according to the Buehler method (3 applications) the substance 2,4-dinitro-1-chlorobenzene at the concentration of 0.5% induced positive skin sensitisation reactions in 33% of the guinea pigs.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
very slight erythema
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 500 mg. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
Reading:
2nd reading
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
very slight erythema
Remarks on result:
other: Reading: 2nd reading. Group: test group. Dose level: 500 mg. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
Reading:
other: 3rd reading
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: Challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: Challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
very slight erythema
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 500 mg. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
Reading:
other: Challenge
Hours after challenge:
72
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 72.0. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: Challenge
Hours after challenge:
24
Group:
positive control
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
Well defined erythema
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Well defined erythema.
Reading:
other: Challenge
Hours after challenge:
48
Group:
positive control
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
Very slight-well defined erythema, dryness of skin
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Very slight-well defined erythema, dryness of skin.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the topical application of undiluted Imexine OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) did not produce sensitisation reactions.
Executive summary:

The potential of the substance to produce sensitisation reactions was assessed according to OECD guideline 406 in compliance to GLP. The sites to be treated were clipped and/or shaved before each induction or challenge application. The concentration of Imexine OAJ used for challenge and induction applications was selected on the basis of the results of a preliminary irritation test where undiluted Imexine OAJ was non-irritant under the conditions of the study. The induction procedure consisted of 3 weekly topical applications of neat Imexine OAJ. On day 1, a moistened gauze pad (about 4 cm2) dampened with 0.5 ml water or loaded with 500 mg neat Imexine OAJ was applied to the anterior left flank of control (5/sex) or treated (10/sex) animals, respectively. It was held in place for 6 hours by an occlusive dressing. This treatment was repeated on day 8 and day 15 of the study. On day 29, following a 2- week rest period, all control and treated animals received under similar conditions a topical challenge application of 0.5 ml water and 500 mg neat Imexine OAJ on posterior left and right flank, respectively. Cutaneous reactions were assessed 24 hours after each dressing removal during the induction period, and 24, 48 and 72 hours after removing the dressing of challenge application.Cutaneous reactions were limited to purple colouration of the skin and very slight erythema in 2/20 treated animals at the 48 hour reading. Under the conditions of the study, the topical application of undiluted Imexine OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) did not produce sensitisation reactions.