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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2003, november 3rd to 2003, noivember 6th
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the OECD Guideline 404.

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 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SRID N°. : DEV5332
Physical State and Appearance : Solid, Tan powder
Source of Test Substance : Eastman Kodak Company

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Test System
Three albino rabbits (Hra:(NZW)SPF) obtained from Covance Research Products, Inc.
(Denver, PA) were assigned to the study. The rabbits were young adults (at least three months
old) and weighed at least 2000 grams at the start of the study. Rabbits were chosen for this study
because they are a common representative species for dermal irritation studies. The rabbot is the
preferred species recommended for use in the OECD Guideline. The protocol was approved by
the Institutional Animal Care and Use Commitee.
Husbandry
Housing
Animals were housed in an Association for Assessment and Accreditation of Laboratory
Animal Care International-accredited vivarium in accordance with the Guide for the Care
and Use of Laboratory Animals (National Research Council, 1996). The rabbots were
singly housed in suspended, stainless-steel mesh cages. Cages and racks were washed
once a week. Absorbent paper, used to collect excreta, was changed every other day.
Environmental Conditions
The study room was maintained at 20.5 to 21.9°C and 46.3 to 56.2% relative humidity.
A photoperiod of 12 hours light was maintained.
Acclimation Period
The animals were isolated upon arrival and allowed to acclimate for a period of 5 days.
Animals were judged to be healthy prior to testing.
Feed
Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum. Feed containers
were cleaned and refilled at least once a week. No known contaminants which would
interfere with the outcome of this study were present in the feed. Analyses of feed are
maintained on file within the testing laboratory.
Water
Water was available ad libitum through an automatic watering system. The source of the
water was the local public water system. There have been no contaminants identified in
previuos water analyses that would be expected to interfere with the conduct of the study.
Semiannual analyses of water are maintained on file within the testing laboratory.
Identification
Upon arrival, all rabbits were identified by uniquely-numbered ear tags. Cage cards
contained the study-specific animal number and the ear tag number.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A single dose of 0.5 grams of test substance was applied topically to each animal using a fiber pad and an occlusive
wrap to hold the test substance in place.
Duration of treatment / exposure:
4 hours.
Observation period:
The site of application was examined at 1, 24, 48 and 72 hours after removal of the
occlusive patch. Observations included estimation of erythema, edema, necrosis, eschar
formation, scarring, erosion, and staining caused by the test substance as well as general
systemic effects.
Number of animals:
3 animals numbered 751, 752 and 753.
Details on study design:
Grading the Irritant Response
The most severely affected area within the test substance application sites were scored for
dermal reactions. Corrsion was considered to have resulted if destruction or irreversible
alteration of the skin tissue (ulceration and/or necrosis) resulted after an exposure of
4 hours or less to the test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
rabbit 751
Time point:
other: 1
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
rabbit 751
Time point:
other: 24
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
rabbit 751
Time point:
other: 72
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
rabbit 752
Time point:
other: 1
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
rabbit 752
Time point:
other: 24
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
rabbit 753
Time point:
other: 72
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
rabbit 753
Time point:
other: 1
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
rabbit 753
Time point:
other: 24
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
rabbit 753
Time point:
other: 72
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
rabbit 751
Time point:
other: 1
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
rabbit 751
Time point:
other: 24
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
rabbit 751
Time point:
other: 72
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
rabbit 752
Time point:
other: 1
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
rabbit 752
Time point:
other: 24
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
rabbit 752
Time point:
other: 72
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
rabbit 753
Time point:
other: 1
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
rabbit 753
Time point:
other: 24
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
rabbit 753
Time point:
other: 72
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
No irritant response or serious lesion was noted during the 72-hour observation period.
Other effects:
No toxic effects were noted during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results, the test substance requires no skin irritation classification as defined in
the 18th Adaptation of the EC Classification, Packaging and Labelling of Dangerous Substances Directive.
Executive summary:

Prior to initiation of the dermal irritation study, a screening procedure was performed in an attempt to avoid testing a substance that might produce corrosion of the skin. First, the pH of the test substance was measured and the value obtained (5.622) demonstrated that the test substance was neither strongly acid (pH < or = 2.0) nor strongly alkaline (pH > or = 11.5). Subsequently, an in vitro test (Corrositex Assay) designed to identify substances that are corrosive to the skin was conducted, but the assay could not be performed due to a qualification issue using this test substance. Therefore, based on the pH value obtained and the lack of any further information on this test substance, an acute dermal irritation study was conducted.

Inthe in vivo rabbit study, no signs of irritation were evident at any time during the observation period. Therefore, the test substance was not considered a dermal irritant.