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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
08 to 22 September 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in a GLP compliant laboratory according to accepted regulatory guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
S-900
IUPAC Name:
S-900
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Name of test material (as cited in study report): S-900
- Physical state: dark brown paste
- Lot/batch No.: 02869
- Storage condition of test material:room temperature In the dark, handled under non-actinic lighting only
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.63 - 2.89kg
- Housing: The animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -23C
- Humidity (%): 30-70%
- Air changes (per hr): ca 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light: 12h dark

IN-LIFE DATES: From: To: 08-22 September 1999

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
None
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72h - Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal flank area
- % coverage: not specified - area of 2.5cm x 2.5cm tested
- Type of wrap if used:A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLEN DERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in acetone.
- Time after start of exposure: 4h

SCORING SYSTEM:
The test sites were scored according to the following scale from Draize J H, (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: moderate desquamation on Day 14
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: moderate desquamation on Day 14
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
2
Reversibility:
other: moderate desquamation on Day 14
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 14 days
Other effects:
Crust formation which prevented accurate evaluation of erythema and oedema was noted at all treated skin sites at the 7-day observation. Moderate desquamation was noted at all treated skin sites at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test material, S-900, produced a primary irritation. index of 3.2 and was classified as a MODERATE IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material produced positive criteria in 2/3 rabbits according to the EU labelling regulations and was classified as IRRITANT to rabbit skin.