Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 October 2000 - 7 November 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: light orange liquid
- Analytical purity: Not specified
- Stability under test conditions: Not specified
- Storage condition of test material: Room temperature and humidity

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA, USA
- Age at study initiation: ca. 3 months Animals born on 2000-07-15
- Weight at study initiation: 2.0 - 2.7 kg
- Housing: Suspended wire cages, 1 rabbit/cage
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321) provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Quarantine period of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled environment, but no information provided
- Humidity (%): controlled environment, but no information provided
- Air changes (per hr): controlled environment, but no air change information provided
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 2000-10-24 To: 2000-11-07

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL/rabbit (2.5 x 2.5 cm area)
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 rabbits ( 2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: 4 ply surgical gauze patch secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water on removal of wrapping.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Erythema was barely perceptible at 60 minutes following patch removal, well defined at 24 and 48 hours, well defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Oedema was barely perceptible at 60 minutes following patch removal, well defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well defined on day 7 and absent by day 14.
Other effects:
There were no abnormal systemic signs noted during the observation period.
Bodyweight changes were normal.

Any other information on results incl. tables

Table 1: Dermal observations, body weights and systemic observation

Rabbit Ear-tag

F5983

F5990

F5955

Sex

M

F

M

Pre-test body weight (kg)

2.7

2.0

2.7

72 h weight (kg)

2.7

2.0

2.8

Day 7 weight (kg)

2.7

2.1

2.8

Terminal body weight (kg)

2.8

2.2

2.8

Time after patch removal

Erythema and Eschar Formation

60 mins

1

1

1

24 hours

2

2

2

48 hours

2

2b*

2

72 hours

3

2p

2p

7 days

1f*

4f*

0f

14 days

0*

0*

0

 

Oedema

60 mins

1

1

1

24 hours

2

2

3

48 hours

1

2

2

72 hours

1

2

2

7 days

1

2

0

14 days

0

0

0

 

Systemic Observations

60 mins

A

A

A

24 hours

A

A

A

48 hours

A

A

A

72 hours

A

A

A

7 days

A

A

A

14 days

A

A

A

A = normal, b = brown areas, f = flaking skin, p = pale areas, *= reclipped

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
Executive summary:

Test Guidance

In accordance with EPA guideline OPPTS 870.2500

Method and Material

Three New Zealand White rabbits were dosed dermally with 0.5 mL of the test material to one intact site per rabbit. Semiocclusive wrapping was applied for 4 hours after which the wrapping was removed and the test site washed. Dermal reactions were scored using the Draize method at 60 minutes, 24, 48 and 72 hours and on days 7 and 14 of the observation period. The skin was also evaluated for ulceration, necrosis or evidence of skin destruction.

Results

Erythema was barely perceptible at 60 minutes following patch removal, well-defined at 24 and 48 hours, well-defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Edema was barely perceptible at 60 minutes following patch removal, well-defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well-defined on day 7 and absent by day 14. Bodyweights were recorded pre-test and termination. There were no abnormal systemic signs noted during the observation period and body weight changes were normal.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.