ferrocene, (4-chlorobutyl)-

Endpoint summary

Description of key information

In an in vivo skin irritation study (OECD 404) test item was not irritating to skin (GLP, Rel. 1)

In an in vivo eye irritation study (OECD 405) test item was not irritating to the eyes (GLP, Rel. 1)

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:

13-17 October 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
SNPE / LD 2332

- Appearence: brown-red liquid
- Name of test item: CL 1038

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
refrigerated under nitrogen
- Solubility and stability of the test substance in the solvent/vehicle:
soluble in common solvents (acetone, hexane, chlorinated solvents)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Abbaye de Bellefontaine, France
- Weight at study initiation: 2.4 ± 0.2 kg
- Housing: Individually housed in polystyrene cages
- Diet (e.g. ad libitum): 112 C pelleted diet (UAR, Villemoisson-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 7 days
- prophylactic treatment during 5 days of the acclimatation period: mucoxid at 140 mg/kg bw/day (Veda-Cogla) added to drinking water

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 h dark / 12 h light

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: right flank (6 cm²)
- Type of wrap if used: Test material was applied to the clipped skin under a gauze pad. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- After removal of the dressing, any residual test item was wiped off by means of a aguze pad with sterilised water.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to OECD guideline 404

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Slight erythema with colouration of skin by the substance was observed 1 h after exposure in all 3 animals. No reaction was recorded thereafter.

Other effects:

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test item is not classified as irritating to skin according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.

Executive summary:

In a primary dermal irritation study performed similarly to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 0.5 mL of the test item under a semi-occlusive dressing. After removal of the residual test item with water, irritation was scored as outlined in the OECD guideline 404 at 1, 24, 48 and 72 h after exposure.

Slight erythema with colouration of skin by the substance was observed 1 h after exposure in all 3 animals. No reaction was recorded thereafter.

Under the test conditions, the test item is not classified as irritating to skin according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.

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:

13-17 October 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
SNPE / LD 2332

- Appearence: brown-red liquid
- Name of test item: CL 1038

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
refrigerated under nitrogen
- Solubility and stability of the test substance in the solvent/vehicle:
soluble in common solvents (acetone, hexane, chlorinated solvents)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Abbaye de Bellefontaine, France
- Weight at study initiation: 2.4 ± 0.2 kg
- Housing: Individually housed in polystyrene cages
- Diet (e.g. ad libitum): 112 C pelleted diet (UAR, Villemoisson-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 7 days
- prophylactic treatment during 5 days of the acclimatation period: mucoxid at 140 mg/kg bw/day (Veda-Cogla) added to drinking water

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 h dark / 12 h light

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

No washing was done.

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing: No
SCORING SYSTEM: OECD guideline 405
TOOL USED TO ASSESS SCORE: - For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution. This evaluation was performed on Day 2 and repeated thereafter whenever necessary.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight chemosis and redness of conjunctive were observed 1 h after administration. Slight redness was osberved in one animal at 24 h. No more reaction was recorded at 48 and 72 h.

Other effects:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, test item is not classified as irritating to eyes according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.

Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of test item in their left eye while the right eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 h after instillation and graded according to the OECD guideline 405. For the evaluation of corneal opacification, the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution. This evaluation was performed at 24 h post-instillation and repeated thereafter whenever necessary.

Slight chemosis and redness of conjunctive were observed 1 h after administration. Slight redness was osberved in one animal at 24 h. No more reaction was recorded at 48 and 72 h.

 

Under the test conditions, test item is not classified as irritating to eyes according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a primary dermal irritation study performed similarly to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 0.5 mL of the test item under a semi-occlusive dressing. After removal of the residual test item with water, irritation was scored as outlined in the OECD guideline 404 at 1, 24, 48 and 72 h after exposure.

Slight erythema with colouration of skin by the substance was observed 1 h after exposure in all 3 animals. No reaction was recorded thereafter.

Under the test conditions, the test item is not classified as irritating to skin according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of test item in their left eye while the right eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 h after instillation and graded according to the OECD guideline 405. For the evaluation of corneal opacification, the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution. This evaluation was performed at 24 h post-instillation and repeated thereafter whenever necessary.

Slight chemosis and redness of conjunctive were observed 1 h after administration. Slight redness was osberved in one animal at 24 h. No more reaction was recorded at 48 and 72 h.

Under the test conditions, test item is not classified as irritating to eyes according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the available information, the registered substance is not classified as skin irritant and eye irritant according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and GHS.