Distillates (coal tar), upper

Endpoint summary

Description of key information

Based on experimental findings with the structure-analogous substance creosote, distillates (coal tar), upper is identified as skin irritating Cat. 2 (CLP regulation) while at the same time not being irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.8 ±0.1 kg
- Housing: polystyrene cage, 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-3
- Humidity (%): 50 +-20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

9 and 12 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: bandage semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water-moistened gauze
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scale with grades 1 to 4 for severity of erythema and oedema
Data evaluation: According to directive 91/325/EEC: irritating = score >= 2 in 2/3 animals for >= 24 h for erythema or oedema

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

average over time

Time point:

other: 24, 48, 72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

average over time

Time point:

other: 24, 48, 72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

average over time

Time point:

other: 24, 48, 72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

average over time

Time point:

other: 24, 48, 72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

average over time

Time point:

other: 24, 48, 72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

average over time

Time point:

other: 24, 48, 72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 h

Score:

2.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 h

Score:

3.1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

Mean scores per animal were 2 or distinctly higher at any time point until 72 h with mean scores over time >2 for erythema (2/3 animals) or >3 for oedema (3/3 animals).

Other effects:

Skin dryness prevailed between day 4 and 11 in 2 animals.

Table for skin irritation study
Score (average of three animals investigated)	time	Erythema	Edema
Average Draize scores (0 to maximum 4)	60 min	2.3	4.0
	24 h	2.7	4.0
	48 h	2.3	3.3
	72 h	1.7	2.0
Average score	24h, 48h, 72h	2.2	3.1
Reversibility: *		c	c
Time for reversibility in all animals (score 0)		7 d	6 d
*   c :    completely reversible   n c :    not completely reversible      n :    not reversible

Interpretation of results:

irritating

Remarks:

Migrated information

Conclusions:

Under the conditions of the test, the test material, creosote SNCF, is irritating to the skin of rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.8 ±0.1 kg
- Housing: polystyren cage, 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-3
- Humidity (%): 50 +-20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

not rinsed

Observation period (in vivo):

1, 24, 48, 72 h post-instillation

Number of animals or in vitro replicates:

3 (male)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:


SCORING SYSTEM: Numeric Draize scale:
Grades 0 to 3 for severity of redness of conjunctivae as well as lacrimation,
grades 0 - 4 for oedema and corneal effects,
grades 0 - 2 for iris effects.
EVALUATION: according to EU classification system

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 animals

Time point:

other: 24, 48, 72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Very slight chemosis (score 1 in one animal only) and slight (score 1) to moderate (score 2) redness of the conjunctivae between 1 and 48 h, the moderate effect in one animal after 24 h. No effect on the iris and cornea.

Other effects:

none

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

All individual effects scores over time remained below cut-off limits for classification: cornea < 2, iris < 1, redness < 2.5, oedema < 2.
Under the conditions of the test, the test material, Creosote SNCF, is not irritating to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on experimental evidence (study according to OECD TG 404 with supporting substance creosote), distillates (coal tar), upper is to be classified as skin irritating Cat. 2 based on criteria of Regulation (EC) No 1272/2008. Test results for eye irritation do not demonstrate a relevant eye irritating potential. Classification for eye irritation is not required.