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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1997
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:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- name of the test substance: Nitrobiphenol (Reg. Nr. 363 986)
- Purity: 99.5 area%
- batch number: 27997/111 Fr.5
- CAS number: 6271-80-3
- date of manufacture: 1997-03-11
- physical state/appearance: liquid, red-clear
- storage: room temperature
- substance number: 97/209

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Mean body weight: males 2.71 kg, female 3.2 kg; young adult animals
- Dr. K. Thomae GmbH, Biberach, FRG
- Acclimatization period for at least one week.
- The rabbits were identified via ear tattoo.
- They were held singly in stainless steel wire mesh cages with grating, floor area: 3000 cm2).
- The rabbits were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night r hythm was 12 h light and 12 h darkness.
- The animals were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Boht eyes of the animals were examined before instillation of the test substance for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
Weight determination shortly before test substance instillation.
Single instillation to the conjunctival sac of the right eyelid; the test substance was washed out with tap water about 24 hours after instilsation (before the 24-h reading).
Readings: 1 h, 24 h, 48 h and 72 h after instillation
A check for dead or moribund rabbits was made twice each working day and once on weekends and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the test substance does not warrant classification for skin irritation according to Directive 67/458/EEC and Regulation (EU) No. 1272/2008.