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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
From April 08 to May 16, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
April 29, 1993
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A Buehler test was already available and used for assessment

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
445-280-9
EC Name:
-
Cas Number:
371921-40-3
Molecular formula:
No molecular formula possible, it is a reaction mass.
IUPAC Name:
docosasodium 4-amino-3-[(1E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-5-hydroxy-6-[(1E)-2-[4-(2-hydroxyethanesulfonyl)-2-sulfonatophenyl]diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-3-[(1E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-5-hydroxy-6-[(1E)-2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-5-hydroxy-6-[(1E)-2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]-3-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-6-[(1E)-2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl]-3-[(1E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate 4-amino-6-[(1E)-2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl]-5-hydroxy-3-[(1E)-2-[2-(2-hydroxyethanesulfonyl)phenyl]diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-6-[(1E)-2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl]-5-hydroxy-3-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan spotted
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 374 - 443 g; animals used for irritation screen: 401 - 416 g
- Housing: individually in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418, batch nos. 02103 and 11/03, guinea pig breeding / maintenance diet, containing Vitamin C (Provimi Kliba AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum
- Acclimation period: One week for the control and test group. However, contrary to the test group the control group remained untreated during the 3 induction weeks. One day for the animals used in the irritation screen for induction and challenge. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG300
Concentration / amount:
50 %
Day(s)/duration:
3 weeks
Challenge
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG300
Concentration / amount:
50 %
Day(s)/duration:
6 hours
No. of animals per dose:
20 animals per dose group, 10 animals per control and 4 animals for irritation screen
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: only one test group at 50 % in PEG 300
- Control group: the control animals remained untreated
- Site: left shoulder
- Frequency of applications: one patch per week
- Duration: 3 weeks
- Concentrations: 50 % in PEG 300

B. CHALLENGE EXPOSURE
- Day(s) of challenge: day 29 after beginning of challenge (2 weeks after last application of induction)
- Exposure period: 6 hours
- Test groups: only one test group at 50 % in PEG 300
- Control group: treated with 50 % test item in PEG 300
- Site: left shoulder
- Concentrations: 50 % in PEG 300
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
Challenge control treated with the test item at 50 % in PEG 300
Positive control substance(s):
yes
Remarks:
ALPHA-HEXYLCINNAMALDEHYDE

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 % in PEG 300
No. with + reactions:
11
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 % in PEG 300
No. with + reactions:
15
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5 % in PEG300
No. with + reactions:
17
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5 % in PEG300
No. with + reactions:
19
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
treated with 50 % test item in PEG 300 at challenge
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
treated with 50 % in PEG at challenge
No. with + reactions:
0
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
other: Category 1B (indication of skin sensitising potential) based on CLP criteria
Conclusions:
Skin sensitizer
Executive summary:

The purpose of this skin sensitizing study was to assess the possible allergenic potential of Navy MGi 1571 when administered topically to albino guinea pigs according to the OECD 406, "BühlerTest".
Twenty male animals of the test group were treated topically with Navy MGi 1571 at 50 % in pEG 300 once a week for a 3 week induction phase. Two weeks after the final  induction application the animals were challenged with the same test item concentration of 50 % in PEG 300 as used for induction.
The ten animals of the control group were not treated during the induction. They were treated once at challenge with Navy MGi 1571 at 50 % in PEG 300.
Eleven (at the 24-hour reading) and fifteen (at the 48-hour reading) out of 20 test animals were observed with discrete/patchy to moderate/confluent erythema after the challenge treatment with the highest tested non-irritating concentration of Navy MGi 1571 at 50 % in PEG300.
No skin reactions were observed in the control group treated in the same conditions during the challenge phase.
Based on the above mentioned findings in a non-adjuvant sensitization test in guinea pigs Navy MGi 1571 applied at a
concentration of 50 % in PEG 300 was found to be as a skin sensitizer.