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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues 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: 3.17 kg (males) ; 2.81 kg (females)
ANIMAL BREEDER: GAUKLER; Germany
ACCLIMATIZATION PERIOD: AT LEAST 8 DAYS

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
TS was not washed out
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
Weight determination: shortly before application of the test material.
Application site: single application to the conjunctival sac of the right eyelid.
Readings: 1 h, 24 h, 47 h and 72 h after application.

SCORING SYSTEM: According to OECD guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Mean scores for conjunctival redness (24h,48h,72h) was 0.7; 0.3; 0.3 for each animal respectively.
For cornea, iris and chemosis, the induvidual and mean scores were 0.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information