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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
04 Mar - 10 Mar 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (analytical purity is not reported, occlusive dressing, residual test substance was not removed)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1983
Deviations:
yes
Remarks:
Analytical purity is not reported, occlusive dressing, residual test substance was not removed.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
97281-24-8
Cas Number:
97281-24-8
IUPAC Name:
97281-24-8
Details on test material:
- Name of test material (as cited in study report): only trade name given- Physical state: yellow liquid- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Chbb: HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Fa. Thomae, Biberach, Germany- Weight at study initiation: 2.5 kg- Housing: individual - Diet: Zucht- / Haltungsdiät - Water: tap water, ad libitum- Acclimation period: at least 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20-21- Humidity (%): 45-50- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
3 daysReading time points: 1, 24, 48 and 72 h
Number of animals:
4 males
Details on study design:
TEST SITE- Area of exposure: back - Type of wrap if used: the treated skin was covered with a linen patch (2.5 cm x 2.5 cm). This was then covered with a large plastic foil, which was held in place with tape. Finally, by mean of a bond a secure fixation was achieved. SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No skin irritations were observed.
Other effects:
No further effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classifiedDSD: not classified