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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
05 Apr - 13 Apr 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given; comparable to standards with restrictions.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Internal BASF-test: occlusive application of unspecified amount for 1 or 15 min, or 2 or 20 h, scoring at end of exposure and after 1, 2, 5, 7 and 8 d, internal scoring system
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): citral, 3,7-dimethyloctadien-2,6-al-1
Purity: >= 95 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.44 and 3.04 kg
- Sex: females

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
not specified
Duration of treatment / exposure:
1 min, 15 min, 2 h and 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: no data

OBSERVATIONS:
- observation of application site: after removal of the patch and on day 1, 2, 5, 7 and 8 after application
- at the end of the study: gross-pathology

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol: water (1:1)
- Time after start of exposure: 1 min, 15 min, 2 h and 20 h

SCORING SYSTEM:
- Erythema: 1 = questionable, 2 = slight, 3 = moderate, 4 = severe
- Edema: 1 = very slight, 2 = slight, 3 = moderate, 4 = severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 1 min
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 1 min
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
2.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 15 min
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 15 min
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
2.75
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 2 hrs
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
2.75
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 2 hrs
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 20 hrs- necroses observed
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hrs
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: treatment time 20 hrs - necroses observed
Irritant / corrosive response data:
Exposures of 1 min, 15 min, and 2 hours lead in all animals to visible inflammation of treated skin areas which still persisted after the 8-day post-observation period. In addition, all animals showed desquamation from day 5 to the end of the observation period. (For details see Tables 1 to 3)
20-hr exposure: both animals showed enhanced inflammation which was not declining during the observation period. Additionally, both animals showed soft and parchment-like necroses indicating a severe irritating potential (for details see Table 4)
Other effects:
Gross-pathology: the preliminary report about the skin was confirmed; organs without findings.

Any other information on results incl. tables

Remark: in all experiments the first reading is done immediately after the end of the exposure time, so the time points given for the readings are calculated starting with the onset of exposure.

Table 1: Skin reactions after a 1-min treatment

Readings

Animal

Exposure period: 1 min

Erythema

Edema

Additional findings

1 min

1

2

0

2

1

0

24 h

1

2

2

2

2

2

48 h

1

2

2

2

2

2

5 d

1

2

1

D

2

2

1

Da

7 d

1

2

1

D

2

2

1

D

8 d

1

2

1

D

2

2

0

D

Mean

24, 48h

1

2

2

2

2

2

Mean

24, 48 h

1-2

2

2

a = finding exceeding beyond area of exposure

D = desquamation

Table 2: Skin reactions after a 15-min treatment

Readings

Animal

Exposure period: 15 min

Erythema

Edema

Additional findings

15 min

1

2

0

2

2

0

24 h

1

2a

2a

2

3a

2

48 h

1

2a

2a

2

3a

2

5 d

1

2a

2a

Da

2

3a

2

Da

7 d

1

2

2

D

2

2a

2

Da

8 d

1

2

1

D

2

2a

1

Da

Mean

24, 48h

1

2

2

2

2.5

2

Mean

24, 48 h

1-2

2.25

2

a = finding exceeding beyond the area of exposure

D = desquamation


Table 3: Skin reactions after a 2 -hr treatment

Readings

Animal

Exposure period: 2 h

Erythema

Edema

Additional findings

2 h

1

2

2

2

2

2

24 h

1

3a

3a

2

2

2

48 h

1

3a

3a

2

3a

3

5 d

1

3a

3a

2

3a

2a

Da

7 d

1

2

3

D

2

3

3

sDa

8 d

1

2

2

D

2

2a

2

sDa

Mean

24, 48h

1

3

3

2

2.5

2.5

Mean

24, 48 h

1-2

2.75

2.75

a = finding exceeding beyond the area of exposure

D = desquamation

s=strong

Table 4: Skin reactions after a 20-hr treatment

Readings

Animal

Exposure period: 20 h

Erythema

Edema

Additional findings (erythema / edema)

20 h

1

-

-

2

-

-

24 h

1

4

3a

Ns

2

4

3

Ns

48 h

1

4

3a

Np

2

4a

3a

Np

5 d

1

4

3

Np

2

4

2

Np

7 d

1

4a

3

Np

2

4

3

Np

8 d

1

4a

2

Np

2

4a

2

Np

Mean

24, 48h

1

4

3

2

4

3

Mean 24, 48 h

1-2

4

3

a = finding exceeding beyond the area of exposure

N = necrosis, s = soft, p = like parchment

Applicant's summary and conclusion