Registration Dossier

Administrative data

Description of key information

Skin irritation (according to OECD TG 404, GLP): not irritating to skin
Eye irritation (according to OECD TG 405, GLP): not irritating to eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Dec 1987 - 02 Jan 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (purity of test substance not specified, first reading time point 30 minutes after patch removal).
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12. May 1981
Deviations:
yes
Remarks:
purity of test substance not specified, first reading time point 30 minutes after patch removal
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2381 - 2433 g
- Housing: individually in screen-bottom stainless steel cages (heavy gauge)
- Diet: measured amount of Purina High Fiber Rabbit Chow
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 29 - 30
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated site of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g (moistened with 0.9% saline) at the site of application

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
reading time points: 0.5, 24, 48 and 72 hours
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: back and flank (approximately 6 cm2)
- Type of wrap if used: 2.5 x 2.5 cm gauze patch, secured with paper tape and loosely overwrapped with Saran Wrap and fixed with Elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tapwater and paper towels
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize Scoring System
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No effects on skin were observed at any reading time point.
Other effects:
No other effects were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Dec 1987 - 01 Jan 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (purity of test substance not specified).
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 12. May 1981
Deviations:
yes
Remarks:
purity of test substance not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2320 to 2501 g
- Housing: individually in screen-bottom stainless stell cages (heavy gauge)
- Diet: measured amount of Purina High Fiber Rabbit Chow
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 39 - 41
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 Dec 1987 To: 01 Jan 1988
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 g (equivalent to 0.1 mL)
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 hours
reading time points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 (1 male and 2 females)
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Slight conjunctival redness and chemosis (Grade 1) was observed at 1 hour for all animals but was completely reversed in two animals within 24 hours and in the third animal within 48 hours.
Other effects:
No pain response was elicited from any animal following instillation of the test material. Blanching of the conjunctivae was observed in one animal at 1 hours.

Table1: Individual Eye Irritation Scores

Cornea

Iritis

Conjunctivae Score

Score

Score

Redness

Chemosis

Animal 1

1 hour

0

0

2

1

24 hour

0

0

1

1

48 hour

0

0

0

0

72 hour

0

0

0

0

Mean scores (24-72 h)

0

0

0,33

0,33

Animal 2

1 hour

0

0

1

1

24 hour

0

0

0

0

48 hour

0

0

0

0

72 hour

0

0

0

0

Mean Scores (24-72 h)

0

0

0

0

Animal 3

1 hour

0

0

1

1

24 hour

0

0

0

0

48 hour

0

0

0

0

72 hour

0

0

0

0

Mean scores (24-72 h)

0

0

0

0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS 107934-68-9) was tested for its skin irritation potential in a study according to OECD 404 (Glaza, 1988). The purity of the test substance was not specified and the first reading time point was after 30 min (60 min suggested in OECD 404, adopted 2002). The shaved skin of 2 male and 1 female rabbits was exposed to 0.5 g test material (moistened with 0.9% saline) for 4 hours under semi-occlusive conditions. No erythema and oedema reactions were observed 30 min, 24, 48, and 72 h after removal of the patch in any animal. In conclusion, the test substance was not skin irritating under the conditions of the study.

Eye irritation

4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS 107934-68-9) was tested for its eye irritation potential in a study according to OECD 405 (Glaza, 1988). The purity of the test substance was not specified. 0.04 g (equivalent to 0.1 mL) test substance was applied in the eye of 1 male and 2 female New Zealand White rabbits each. No washing was performed and the eyes were scored 1, 24, 48, and 72 h after instillation of the test substance. No effects on cornea and iris were observed in any animal at any reading time point. Slight redness and chemosis (score 1-2) were observed 1 h after instillation in all 3 animals. In 2 animals the effects on the conjunctivae were fully reversible within 24 h. In 1 animals redness and chemosis were also observed after 24 h (score 1), but it was fully reversible within 48 h. The mean values over 24, 48, and 72 h were 0 for cornea and iris in all animals. For redness and chemosis the mean values over 24, 48, and 72 h were 0 in 2 animals and 0.33 in 1 animal. The effects were fully reversible within 48 h. In conclusion, the test substance was not irritating to the eyes under the conditions of the study.


Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available.

Justification for classification or non-classification

The available data on skin and eye irritation of 4,4´-(9H-fluoren-9 -ylidene)bis(2 -chloroaniline) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.