Tar bases, coal, lutidine fraction

Endpoint summary

Description of key information

Skin irritation/corrosion: corrosive to skin (in vivo)

Eye irritation/corrosion: corrosive to eyes (based on in vivo skin irritation/corrosion result)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Remarks:

This in vivo study was performed, before the amendments to the data requirements in Annex VII and VIII came into force.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

- Principle of test: A single rabbit was used in an initial assessment of the skin irritation potential of the test substance. The neat substance was applied to the shorn skin of the rabbit under a semi-occlusive dressing for 3 minutes or one hour.
- Short description of test conditions: The animal was exposed via the skin to ca. 0.5 mL of the neat substance applied to each of 2.5 cm square areas on the left flank of the shorn dorso-lumbar region under a semi-occlusive dressing for 3 minutes or one hour. On removal of the dressings, the skin was cleansed with clean, warm water.
- Parameters analysed / observed: The application sites were assessed for erythema and oedema, using the Draize scale, immediately after the removal of the dressings and at one hour after removal of the dressings for the three minute application.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 3236 g
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reporte
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

3 minutes and 1 hour

Observation period:

Not applicable

Number of animals:

One animal was used in the initial study. Due to the severity of the responses seen, the animal was terminated after one hour following the initial application and no further animals were dosed.

Details on study design:

TEST SITE
- Area of exposure: ca. 2.5 cm square
- % coverage: not reported
- Type of wrap if used: not reported

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleansed with clean warm water
- Time after start of exposure: one hour

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): immediately after cleansing of the skin

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

4

Max. score:

4

Reversibility:

other: not tested

Remarks:

Animal was sacrificed after 1 hour due to severity of effects

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 3 minutes

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

4

Max. score:

4

Reversibility:

other: not tested

Remarks:

Animal was sacrificed after 1 hour due to severity of effects.

Irritant / corrosive response data:

Following a single three-minute application of the test substance, well defined erythema was seen up to one hour after application. Severe oedema was also seen one hour after application. Severe erythema and severe oedema were seen immediately after decontamination following a single one-hour application. Large areas of black necrosis were also seen on the application site.

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

The substance was corrosive to the skin of a rabbit treated with a single dermal dose of the neat substance for 1 hour.

Executive summary:

The skin irritation/corrosion potential of the substance was studied in this in vivo study under non GLP following the principle of the OECD regulatory guideline. The experiment is considered relevant, adequate and conclusive.

One male New Zealand White albino rabbit, weighing 3236 g, was used for an initial assessment of the irritation potential. Approximately 0.5 mL of the neat test substance was applied to each of two 2.5 cm square areas on the left flank of the shorn dorso-lumbar region under a semi-occlusive dressing for three minutes or one hour. On removal of the dressing, the skin was cleansed with clean warm water. The application sites were assessed for erythema and oedema, using the Draize scale, immediately after the removal of the dressings and at one hour after the removal of the dressing for the 3-minutes application. Any other signs of skin irritation were also noted. Following a single three-minute application of the test substance well-defined erythema was seen up to one hour after application. Severe oedema was also seen one hour after application. Severe erythema and severe oedema were seen immediately after cleansing of the application following a single one-hour application. Large areas of black necrosis were also seen on the application site. Due to the severity of the responses seen, the animal was sacrificed after one hour following the initial application and no further animals were dosed.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Reference 2

Endpoint:

eye irritation: in vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available in vivo study on the skin irritation potential of the substance is reliable, relevant and appropriate for the derivation of a classification for irritation and corrosion. Based on the results of the in vivo study, the substance has to be classified as follows under the CLP Regulation (EC) No. 1272/2008:

Skin irritation/corrosion: Cat. 1B (this covers also effects on eyes)