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Administrative data

Description of key information

Mild skin irritation was observed in rabbits for a read-across source substance of Benzene, C15 -16 -alkyl derivs., with signs of erythema persisting in some animals through day 7. Though the irritation was mild, it was not fully reversible during the study period.  No signs of eye irritation were observed in rabbits.

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
Study period:
June 15, 1992 - June 22, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standards.
Qualifier:
according to guideline
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5-3.5 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 degree C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): 25 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: June 15, 1992 To: June 22, 1992
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated areas of same animal were used as controls
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hrs
Observation period:
0, 24, 48, and 72 hrs, and 5 and 7 days after removal of the patches
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm gauze pads secured by thin bands of adhesive wrap, then covered with rubberized cloth


SCORING SYSTEM: Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
0.62
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Erythema (maximum score of 2) was seen in all animals at the 24 hr observation. In 3 of the animals, the erythema persisted throughout the experiment, and was not fully resolved by the end of the experiment on day 7. Edema was seen in one animal at the 24 hr observation only.

Results of Skin Irritation Study

Time after patch removal

Animal

Erythema

1

2

3

4

5

6

Mean

1 hr

0

0

0

0

0

0

0.00

24 hrs

2

1

2

1

1

1

1.33

48 hrs

2

1

1

1

1

1

1.17

72 hrs

1

1

1

1

1

1

1.00

5 days

1

1

1

1

1

1

1.00

7 days

0

0

1

0

1

1

0.50

Oedema

1 hr

0

0

0

0

0

0

0.00

24 hrs

1

0

0

0

0

0

0.17

48 hrs

0

0

0

0

0

0

0.00

72 hrs

0

0

0

0

0

0

0.00

5 days

0

0

0

0

0

0

0.00

7 days

0

0

0

0

0

0

0.00

Interpretation of results:
Category 3 (mild irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance caused only mild irritation, however, symptoms were not fully resolved by the end of the experiment.
Executive summary:

In cases where no data were available on the target substance, Benzene, C15 -16 -alkyl derivs., data were read across from a structurally related material (the test substance).

This study examined the potential of the test substance to cause skin irritation. 6 rabbits were exposed to undiluted test substance on shave skin for 4 hrs. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hr observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of edema (score of 1). There were no signs of edema in any animal at the 48 hr observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June 15, 1992-June 22, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standards.
Qualifier:
according to guideline
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5-3.5 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 degree C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): 25 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: June 15, 1992 To: June 22, 1992
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48, and 72 hrs, and 7 days after start of exposure
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize


Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No signs of irritation or corrosion were seen in any animal during any of the observations.

Results of Eye Irritation Study  - Mean Scores                  

Observation

Cornea

Iris

Conjunctiva (Redness)

Conjunctiva (Chemosis)

1 hr

0

0

0

0

24 hrs

0

0

0

0

48 hrs

0

0

0

0

72 hrs

0

0

0

0

7 days

0

0

0

0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an eye irritant according to EU GHS guidelines.
Executive summary:

In cases where no data were available on the target substance, Benzene, C15 -16 -alkyl derivs., data were read across from a structurally related material (the test substance).

This study examined the potential of the test substance to cause eye irritation. 0.1 ml of test substance was placed in one eye of 6 rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hrs, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation. The test substance is considered no irritating to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Mild skin irritation was observed in rabbits for a read-across source substance of Benzene, C15 -16 -alkyl derivs., with signs of erythema persisting in some animals through day 7. Though the irritation was mild, it was not fully reversible during the study period. No signs of eye irritation were observed in rabbits in relation to the read-across source substance.

The dermal irritation key study (ANON 1992, Biolab SGS, Report No. 91-924.A1) examined the potential of a read-across source substance for Benzene, C15-16-alkyl derivs. to cause skin irritation in rabbits. Six rabbits were exposed to undiluted test substance on shaved skin for 4 hours. About 1 hour after the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 hours after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after the end of the exposure. At the 24 hour observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of edema (score of 1). There was no signs of edema in any animal at the 48 hour observation. Erythema persisted in all animals through day 5, and in three of the animals erythema was not fully resolved at the end of the experiment on day 7. All symptoms of irritation were mild, although the irritation was not fully reversible within the study period. Based on these data, Benzene, C15-16-alkyl derivs. is not considered a skin irritant by CLT criteria. Test animals were also scored for corrosivity, with results supporting the conclusion that Benzene, C15 -16 -alkyl derivs. is not corrosive to skin.

The eye irritation key study (ANON 1992, Biolab SGS, Report No. 91-924.A1) examined the potential of a read-across source substance for Benzene, C15-16-alkyl derivs. to cause eye irritation in rabbits. An aliquot of 0.1 ml of the test substance was placed in one eye of each of six rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hrs, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation period. Therefore, the test results support the conclusion that Benzene, C15 -16 -alkyl derivs. is not irritating to eyes.

Justification for classification or non-classification