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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(11E)-11,12-dibromo-7-(chloromethyl)-2,6,9,14,18-pentaoxanonadec-11-ene-4,16-diol; (12E)-12,13-dibromo-1,21-dichloro-8-(chloromethyl)-5,17-bis(methoxymethyl)-4,7,10,15,18-pentaoxahenicos-12-ene-2,20-diol; (8E)-8,9-dibromo-13-(hydroxymethyl)-2,6,11,15-tetraoxahexadec-8-en-4-ol; (8E)-8,9-dibromo-2,6,11,15-tetraoxahexadec-8-ene-4,13-diol
EC Number:
617-903-6
Cas Number:
86675-46-9
Molecular formula:
(C4H9O2)xC4H4O2Br2(C4H9O2)y with (x+y)= 2.5
IUPAC Name:
(11E)-11,12-dibromo-7-(chloromethyl)-2,6,9,14,18-pentaoxanonadec-11-ene-4,16-diol; (12E)-12,13-dibromo-1,21-dichloro-8-(chloromethyl)-5,17-bis(methoxymethyl)-4,7,10,15,18-pentaoxahenicos-12-ene-2,20-diol; (8E)-8,9-dibromo-13-(hydroxymethyl)-2,6,11,15-tetraoxahexadec-8-en-4-ol; (8E)-8,9-dibromo-2,6,11,15-tetraoxahexadec-8-ene-4,13-diol
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): IXOL M125
- Physical state: treacly liquid
- Lot/batch No.: 1013
- Purity: >99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TNO, Zeist, The Netherlands
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel wire cages. Sawdust, woodchips, or other extraneous material that might produce skin irritation were excluded.
- Diet: 80 g food ( a standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands) per day during the acclimatization period. During the experiment, food was available ad libitum.
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 55-65
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Remarks:
A sample was slightly moistened with 1%-tragacanth suspension.
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
30-60 min, 24, 48 and 72 hours after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was wiped
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Neither erythema nor edema were observed at any of the readings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to skin.
Executive summary:

In a GLP compliant skin irritation study, performed according to OECD guideline 404, 0.5mL of the test substance was applied occlusive on the shaved skin of three male New Zealand White rabbits for 4 hours. Observation were made at 30-60 minutes, and at 24, 48, and 72 hours after patch removal. There was neither erythema nor oedema at any of the readings and therefore Polyol Ixol M125 is considered to be not irritant to the skin.