1,1'-Biphenyl, 4'-chloro-2-nitro-

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Mean body weight: male 3.99 kg, females 3.94 kg; young adult animals
- Supplier: 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

The test patches (2.5 x 2.5 cm) were moistened with a dose of 0.5 ml of the liquid test substance.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

At least 24 hours before study start, the fur was removed by clipping the dorsal part of the trunk of the animals. Only animals with healthy intact skin have been used.
Weight determination shortly before test substance application.
A check for dead or moribund rabbit was made twice each working day and once on weekends and on public holidays.
Application site: upper third of the back or flanks
Readings: 1 h, 24 h, 48 h and 72 h after removal of the test patches
The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

other: 24 - 48 - 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual scores: 1 - 0 - 0

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual scores: 2 - 1 - 0

Results 3

Irritation parameter:

edema 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 eye irritation according to Directive 67/458/EEC and Regulation (EU) No. 1272/2008.