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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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:
p-Nitrobenzoic acid-2-ethylhexylester
EC Number:
605-350-3
Cas Number:
16397-70-9
Molecular formula:
C15 H21 N O4
IUPAC Name:
p-Nitrobenzoic acid-2-ethylhexylester
Details on test material:
Name of the test substance used in the study report: p-Nitrobenzoesaeure-2-ethylhexylester
Purity: 99.5% (GC)
- Physical state: LIQUID, LIGHT YELLOW
- Lot/batch No.: 22 170/85
- Stability under test conditions: WAS CONFIRMED BY ANALYSIS
- Storage condition of test material: ROOM TEMPERATURE

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
The animals were held in stainless steel cages (40 x 51 cm; no bedding in the cages - sawdust in the waste trays). They were identified via ear tattoo. The animals were housed in fully air-conditioned rooms with central air-conditioning in a range fo 20 - 24°C for temperature and 30-70% for relative humidity. The light/dark rhythm was 12 h dark and 12 h light. A standardized animal diet were offered (about 130 g per animal and day); about 250 ml tap water per animal and day was available.

Mean weight at study initiation: 2.43 kg (males) ; 2.23 kg (females)
ANIMAL BREEDER: GAUKLER; Germany
ACCLIMATIZATION PERIOD: AT LEAST 8 DAYS

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of the fur
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (1 female, 2 males)
Details on study design:
Clipping of the fur: at least 15 h before the beginning of the study.
Weight determination: shortly before application of the test substance.
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks


REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period with Lutrol and Lutrol/water (1:1)


SCORING SYSTEM: according to OECD guideline
Readings: 30 - 60 min after removal of the test patches and 24 h, 48 h and 72 h after the beginning of application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

No dermal reactions have been observed under the conditions of this study. The present data on skin irritation do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information