Registration Dossier

Administrative data

Description of key information

Skin irritation: with 20 h exposure time well-defined erythema and edema (Grade 2) were observed after 24 h; after 8 days only scaling was reported
Eye irritation: slight reddening of conjunctivae (Grade 1) was observed after 24 h (fully reversible within 8 days)
Not to be classified as skin or eye irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Reference:
Composition 0
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 information:
Composition 1
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
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
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.

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

 

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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 equivalent or similar to guideline study.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
method applied according to BASF-internal standard
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.11 - 3.32 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
Vehicle:
unchanged (no vehicle)
Controls:
other: 0.05 mL of a NaCl solution was applied into the other eye of the same animal
Amount / concentration applied:
0.05 mL
Duration of treatment / exposure:
Single instillation into the conjunctival sac of the right eyelid
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed out

SCORING SYSTEM: observed were the parameters redness conjunctivae, chemosis, cornea opacity, and necrosis
Grading system for cornea and chemosis:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"fraglich" (+): considered as equivalent to Grade 1 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 2 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 3 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 4 according to OECD Guideline 405

Grading system for conjunctivae:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 1 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 2 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 3 according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritant / corrosive response data:
After 1 h the treated eye was covered by a smeary layer (reversible after 8 days)
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The skin irritation was tested in 1973 by a study equivalent or similar to OECD Guideline 404. The test substance was applied in a single dose (occlusive) to the clipped skin (back and ear) of an experimental animal; untreated skin areas of the test animal served as the control. The degree of irritation was read and scored at 1 min, 5 min, and 15 min (treated skin was washed). In addition skin was treated for 20 hours and not washed; these observations were recorded after 24 hours and 8 days. With 20 hours treatment the test item exhibited well-defined erythema and edema (Grade 2) after 24 hours. On day 8 these effects were reversed, with scaling still being reported.

Eye irritation:

The eye irritation was tested in 1973 with a study equivalent or similar to OECD Guideline 405. The test substance was applied in a single dose to one of the eyes of the experimental animal; the untreated eye served as the control. The degree of eye irritation was evaluated by scoring lesions of conjunctiva and cornea at 24 hours and 8 days. A slight reddening of the conjunctivae (Grade 1) was observed after 24 hours, which proved to be fully reversible within the 8 days observation period.


Justification for selection of skin irritation / corrosion endpoint:
Applicable to endpoint study, method equivalent or similar to guideline study.

Justification for selection of eye irritation endpoint:
Applicable to endpoint study, method equivalent or similar to guideline study.

Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

Skin irritation

 

Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance has to be classified for skin irritation (R38) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The reported effects were less severe than the classification criteria as set out in EC Regulation 1272/2008 (mean value of ≥ 2.3 - ≤ 4.0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal). The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

 

 

Eye irritation

 

Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC.
As a result and according to the harmonised Annex I classification the substance is not considered to be classified for eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The reported effects were less severe than the minimum classification criteria for conjunctival redness >=2 as set out in EC Regulation 1272/2008. No further eye irritating effect observed. The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified for eye irritation.