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:
from 20 Jan 2003 to 3 Feb 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
This study was conducted largely according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observations only to 7 days, when effects still evident
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA
- Age at study initiation: "young adult"
- Weight at study initiation: 3.018-3.171 kg
- Housing: 1/suspended wire mesh cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-19
- Humidity (%): 43.6-48.0. (The summary indicates the maximum humidity was 49.3%, the data provided do not appear to support this.)
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 2003-01-20 To: 2003-02-03 (14 days - although observational data are only given for 7 days)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat
Duration of treatment / exposure:
3 min
1 h
4 h
Observation period:
3-min: immediately and 1 (or 24) h
1-h: immediately and 24, 48, 73 h, and days 4 and 7
4-h: 1, 24, 48, 73 h, and days 4 and 7
Number of animals:
1 rabbit: 3-min, 1 h, 4 h
2 further rabbits: 4 h
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: not stated
- Type of wrap if used: 2-ply gauze secured with Micropore tape, overwrapped with gauze binder secured with Dermiform tape.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 3 min, 1 h, 4 h

SCORING SYSTEM: Draize, 1965. Mean of 1, 24, 48, 72 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1, 24, 48, 72 h mean
Score:
1.8
Max. score:
8
Reversibility:
other: effects evident at 7 days, no data given after 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days, no data given after 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days, no data given after 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
4-Hour exposure caused erythema and oedema (grade 1 or 2) in up to three animals; erythema persisted to the final observation at 7 days. See tables 1-3.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal after exposure for 3 minutes, at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

Immediately after exposure

0

0

1 h*

0

0

Reversibility*

n/a

n/a

* the text describes a second observation at 1 h, the tabulated data describes the second observation at 24 h.

** Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Table 2: Irritant/corrosive response data for each animal after exposure for 1 hour, at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

Immediately after exposure

0

0

24 h

1

0

48 h

1

0

72 h

2a

1

4 days

1

1

7 days

0b

0

Reversibility*

c

n/a

Average time (unit) for reversion

7 days

 

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

a erythema spreading outside dosed site to

b = desquamation

Table 3: Irritant/corrosive response data for each animal after exposure for 4 hour, at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

0/1/0

0/0/0

24 h

1/2/1

0/2/1

48 h

1/2/1

0/1/0

72 h

2a/2/1

1/1/1

4 days

2/1b/1

1/1/1

7 days

0b/1b/1b

0/0/0

Average 24 h, 48 h, 72 h (EU criteria)

1.3/2/1

0.3/1.3/0.7

Average 1 h, 24 h, 48 h, 72 h (as given in report); PII=1.8

1.2

0.6

Reversibility*

unclear

c

Average time (unit) for reversion

No data at 14 days

Day 7

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

a erythema spreading outside dosed site to

b = desquamation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
A reliable study conducted broadly in accordance with OECD 404 and GLP, found the test material to be slightly irritating to the skin of rabbits. According to EU criteria, classification as a skin irritant is required since the observed effects were not reversed at the end of the study.