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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
08 Jul - 16 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in Apr 2002
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-isopropylidenedi-o-cresol
EC Number:
201-240-0
EC Name:
4,4'-isopropylidenedi-o-cresol
Cas Number:
79-97-0
Molecular formula:
C17H20O2
IUPAC Name:
4,4'-isopropylidenedi-o-cresol

Test animals

Species:
rabbit
Strain:
other: Japanese white species (Kbs:JW)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ina Breeding Center, Kitayama Labes, Co., Ltd., Nagano, Japan
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.71 - 2.38 kg
- Housing: The animals were individually housed in aluminium cages (W350 x D550 x H350 mm) in stainless-steel automatic-washing racks.
- Diet: pelleted diet RC4 (Lot. No. 160330, 160414 from Oriental Yeast Co., Ltd.), 150 g/day
- Water: municipal tap water, ad libitum
- Acclimation period: 8 - 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 - 25.9
- Humidity (%): 48.2 - 65.4
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 Jul 2016 To: 23 Jul 2016

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped and thereafter shaved
Vehicle:
other: olive oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.5 mL olive oil was dropped and blended well with the test substance.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the dorsal area of the drunk

REMOVAL OF TEST SUBSTANCE
- After patch removal, the test substance remaining on the skin was removed as much as possible (not further specified)

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No skin reaction was observed on the skin in any rabbit after 24, 48 and 72 h of observation.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
A reliable study conducted in accordance with OECD 404 and GLP, found the test material to be non-irritating to the skin of rabbits.