Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973-12-18 to 1975-03-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable, method eqivalent or similar to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
method applied according to BASF-internal standard
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1973-12-18 To: 1973-12-27

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: ca. 1 mL
Duration of treatment / exposure:
The test substance was applied for 1 min, 5 min, 15 min 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:
Application to ear: a cotton ball soaked with test item was fixed to the ear
Application to back: a small piece of cloth was fixed to the back with the help of a gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing: After the short-term applications the test substance was washed off with Lutrol; after the 20-hour application the test substance was not washed off.
- Time after start of exposure: 1 min, 5 min and 15 min

SCORING SYSTEM: observed were the parameters erythema, edema, scaling, and necrosis
Grading system:
"reizlos" Ø: considered as equivalent to Grade 0 (no irritating effect) according to OECD Guideline 404
"fraglich" (+): considered as equivalent to Grade 1 (very slight erythema (barely perceptible)) according to OECD Guideline 404
"leicht" +: considered as equivalent to Grade 2 (well-defined effect) according to OECD Guideline 404
"stark" ++: considered as equivalent to Grade 3 (moderate (to severe)) effect according to OECD Guideline 404
"sehr stark" +++: considered as equivalent to Grade 4 (severe effect) according to OECD Guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: incipient scaling after 8 days
Remarks on result:
other: 20-hour application to back
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: incipient scaling after 8 days
Remarks on result:
other: 20-hour application to back
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: incipient scaling after 8 days
Remarks on result:
other: 20-hour application to back
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: incipient scaling after 8 days
Remarks on result:
other: 20-hour application to back
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: incipient scaling after 8 days
Remarks on result:
other: 20-hour application to back
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: incipient scaling after 8 days
Remarks on result:
other: 20-hour application to back
Irritant / corrosive response data:
Application to ear for 20 hours resulted in Grade 3 erythema and edema after 24 hours. Erythema and edema not reported on day 8, however eschar was observed.

Any other information on results incl. tables

Table of results (20 h application of test item) based on grading system as applied in the study report

   

time

animal 1

animal 2

erythema

24 h

+

+

8 d

Ø

Ø

edema

24 h

+

+

8 d

Ø

Ø

scaling

24 h

Ø

Ø

8 d

+

+

 

Table of results (20 h application of test item) translated into the grading system as applied in OECD Guideline 404

  

time

animal 1

animal 2

erythema

24 h

2

2

8 d

0

0

edema

24 h

2

2

8 d

0

0

scaling

24 h

0

0

8 d

2

2

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information