Fluorobenzene

Endpoint summary

Description of key information

Skin irritation/corrosion: non-irritant (m); rabbit; according to OECD TG 404; GLP; K1; undiluted 0.5 mL test substance

Eye irritation: serious damage (m); rabbit; no guideline followed; GLP not specified; K2; 0.1 mL test substance as 10, 5, or 1 % solution     --> Cat. 1, H318: causes serious eye damage

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

observation period 16 days

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Limited, Wyton, Huntingdon
- Age at study initiation: young adult
- Housing: single housing in aluminium cages with grid floors beneath which were peat moss filled trays
- Diet: Standard Rabbit Diet (Special Diets Services, Witham, Essex) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 52 (mean)
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted

Duration of treatment / exposure:

4 hours

Observation period:

16 days; skin reactions were assessed 1 h, 24 h, 48 h, 72 h, 7 d and 16 d after patch removal

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 cm x 2.5 cm patch of gauze covered with Micropore tape, and the trunk was loosely bound with Elastoplast Elastic Bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with water dampened tissues
- Time after start of exposure: 4 hours

SCORING SYSTEM: OECD recommended scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.333

Max. score:

4

Reversibility:

fully reversible within: 16 d

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

other: animals #1 - #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight erythema was noted in one rabbit 72 h and 7 days after patch removal. This reaction had fully reversed by 16 days after patch removal. No other reactions were noted.

Skin Reaction Scores:

Rabbit No.	Erythema						Edema
	1 h	24 h	48 h	72 h	7 d	16 d	1 h	24 h	48 h	72 h	7 d	16 d
1	0	0	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0
3	0	0	0	1	1	0	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

Fluorobenzene is practically non-irritationg to rabbit skin.

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

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only secondary literature available. Peer-reviewed database.

Principles of method if other than guideline:

0.1 ml TS was instilled into the conjunctival sac of the rabbit eye either neat or as a 10, 5 or 1% solution in sesame oil. The eyes were examined 1, 3, 7, 24, 48 and 72 hours and 6 days after instillation.

GLP compliance:

no

Species:

rabbit

Vehicle:

other: sesame oil

Amount / concentration applied:

- Amount applied: 0.1 ml
- Concentration: undiluted, 10, 5 or 1%

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: not specified

Score:

> 0

Reversibility:

not specified

Remarks on result:

other: after application of 0.1 ml undiluted TS

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: not specified

Score:

> 0

Reversibility:

not specified

Remarks on result:

other: after application of 0.1 ml undiluted TS

Irritant / corrosive response data:

The neat substance caused redness and severe cloudy swelling of the conjunctiva in all test animals. In addition 4 out of 5 rabbits showed slight clouding of the cornea (no data on reversibility). The dilutions had no irritant effects. Fluorobenzene was classified as severely irritating to the eye.

The neat substance caused redness and severe cloudy swelling of the conjunctiva in all test animals. In addition 4 out of 5 rabbits showed slight clouding of the cornea (no data on reversibility). The dilutions had no irritant effects. Fluorobenzene was classified as severely irritating to the eye.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008.

Based on the available data that only one of three animals showed a slight and albeit reversible reaction to the test substance a classification for skin irritation / corrosion is not justified under Regulation No. 1272/2008, as amended for the seventeenth time in Regulation (EC) No. 2021/849.

For eye irritation the test substance treatment caused an irritant reaction in the eyes of 4 out of 5 animals and with no data available on reversibility this warrants the classification for serious eye damage Cat. 1 under Regulation (EC) No. 1272/2008, as amended for the seventeenth time in Regulation (EC) No. 2021/849.