Dichlobenil

Endpoint summary

Description of key information

SKIN

The test material was determined to be non-irritating according to a study performed in line with OECD Guideline 404 and EPA Guideline OPP 81-5.

EYE

The test material was determined to be non-irritating according to a study performed in line with OECD Guideline 405 and EPA Guideline OPP 81-4.

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:

03 June 1985 to 06 June 1985

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:

(three animals instead of six used)

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

yes

Remarks:

(three animals instead of six used)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0-2.5 kg
- Housing: stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-20 °C
- Humidity: 685-85 %
- Air changes: 16 times per hour
- Photoperiod: 12 hours light/12 hours dark

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

test material moistened with 1 % tragacanth suspension

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Three

Details on study design:

TEST SITE
- Type of wrap if used: 6 cm^2 aluminium foil patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and eschar formation
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness); eschar formation (injuries in depth) - 4

Oedema formation
No oedema - 0
Very slight oedema (barely perceptible) - 1
Slight oedema (edges of area well-defined by definite raising) - 2
Moderate oedema (raised approximately 1 mm) - 3
Severe oedema (raised more than 1 mm, extending beyond the area of exposure) - 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema or oedema was noted during the exposure or during the 72-hour observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, the test material was determined to be non-irritating.

Executive summary:

In a GLP compliant skin irritation study conducted in line with standardised guidelines OECD 404 and EPA OPP 85-1, the skin irritation of the test material was determined.

Under the conditions of the test, the test material was determined to be non-irritating.

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:

25 April 1983 to 02 May 1983

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:

yes

Remarks:

(three animals instead of six used)

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

yes

Remarks:

(three animals instead of six used)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-21 °C
- Humidity: 60-80 %
- Air changes (per hr): 16 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 g

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Three

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Cornea
A. Opacity-degree of density
No ulceration or opacity - 0
Scattered or diffuse areas; details if iris clearly visible - 1
Easily discernible translucent areas, details of iris slightly obscured - 2
Opalescent areas of opacity, no details of iris visible, size of pupil barely discernible - 3
Opaque, iris invisible -4

B. Area of cornea involved
No damaged cornea - 0
One quarter (or less) but not zero - 1
Greater than one quarter but less than one half - 2
Greater than one half less than three quarters - 3
Greater than three quarters up to whole area - 4

Iris
Normal - 0
Folds above normal, congestion, swelling, circumcorneal injection (any one or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any one or all of these) - 2

Conjunctiva
A. Redness
Vessels normal - 0
Vessels definitely injected above normal - 1
More diffuse, deeper crimson read, individual vessels not easily discernible - 2
Diffuse beefy red - 3

B. Chemosis
No swelling - 0
Any swelling above normal - 1
Obvious swelling with partial eversion of the lids - 2
Swelling with lids about half closed - 3
Swelling with lids about half closed to completely closed - 4

C. Discharge
Normal - 0
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) - 1
Discharge with moistening of the lids and hairs just adjacent to the lids - 2
Discharge with moistening of the lids and considerable area around the eye - 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No effects were observed on cornea, iris or conjunctiva.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, the test material was determined to be non-irritating.

Executive summary:

In a GLP compliant eye irritation study conducted in line with standardised guidelines OECD 405 and EPA OPP 81-4, the eye irritation of the test material was determined.

Under the conditions of the test, the test material was determined to be non-irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

The key study (Koopman, 1985) was performed in line with GLP and standardised guidelines with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard and was assigned a reliability score of 1 using the principle for assessing data quality as set out in Klimisch (1997).

Eye

The key study (Koopman, 1983) was performed in line with GLP and standardised guidelines with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard and was assigned a reliability score of 1 using the principle for assessing data quality as set out in Klimisch (1997).

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin and eye corrosion or irritation.