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Diss Factsheets

Administrative data

Description of key information

- highly irritating to skin

- irreversible effects on the eyes

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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: other: BASF-test.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Diet (e.g. ad libitum): Ssniff
- Weight at study initiation: mean 2.91 kg (4h); mean 2.8 kg (1h)
Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin
Amount / concentration applied:
- about 1 g of the undiluted test substance was applied to an area of 2.5 x 2.5 cm.
- occlusive dressing
- no washing of the exposed area
Duration of treatment / exposure:
4 hour(s), 1 hour
Observation period:
8 days
Number of animals:
2 (4 h); 4 (1h)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 and 48 h
Score:
2
Max. score:
4
Reversibility:
other: observation period only 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 and 48 h
Score:
2.5
Max. score:
4
Reversibility:
other: observation period only 8 days
Irritation parameter:
edema score
Basis:
other: animal #1 and #2
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
other: observation period only 8 days
Remarks on result:
other: overall edema
Other effects:
- superficial necrosis observed on day 8 (animal #1).
- loose incrustation on day 8 (animal #2).

Animal No.

4 hour

1 day

2 days

8 days

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

2

2

2 e

2 e

2 e

2 e

Nds

0

2

2

2

2 e

2 e

3 e

2 e

Cr

0

 

e: extending beyound the area of exposure

Nds: dot-like superficially necrosis

Cr: crust removable, intakt skin under

Animal No.

1 hour

1 day

2 days

8 days

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

0

0

2

1

1

0

0 S

0

2

1

0

2 e sn

2 e

3 e sn

2

4 Np

2

3

1

1

2 e

3 e

2 e sn

2 e

0 S

0

4

1

1

2 e

3 e

2 e

2 e

0 S

0

 

e: extending beyound the area of exposure

sn: spotted necrotic-like skin areas

np: necrosis, parchment-like

S: scaling

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the results of this study, the test substance homoveratrylamin is highly irritating to skin.
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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
BASF-test, according to method described in Federal Register 38, No. 187, para. 1500.42, S. 27029, 1973-09-27.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- food: SSNIFF, Intermast
- mean weight at study initiation: 2.76 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
0.1 mL of the undiluted test item
Duration of treatment / exposure:
8 days, since no wash out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: cornea opacity (1-4); iritis (1-4); chemosis (1-3); conjunctivae redness (1-3).
Irritation parameter:
iris score
Basis:
other: animal #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individaul scores: 1 - 1 - 1;
Irritation parameter:
cornea opacity score
Basis:
other: animal #1 and #3
Time point:
other: 24 - 48 - 72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 3 - 3 - 4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 3 - 3 - 3
Irritation parameter:
conjunctivae score
Basis:
other: animal #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritation parameter:
chemosis score
Basis:
other: animal #1 and #2
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 3 - 2 - 2
Other effects:
- after 24 hours: scar formation (1 animal) and pyesis (1 animal).
- after 48 hours: scar formation (3 animals) and pyesis (3 animals).
- after 72 hours: scar formation (3 animals) and pyesis (3 animals).
- after 8 days: pyesis (two animals), scar formation (3 animals) and staphyloma formation (2 animals).

Time

Animal

Trübung

Iris

Rötung

Schwellung

Remarks

24 h

1

3

1

2

2

SC

2

3

1

2

2

S/sp

3

3

1

2

2

 

48 h

1

3

1

2

2

SC/S

2

3

1

2

2

SC/S

3

3

1

2

2

SC/S

72 h

1

4

1

2

2

SC/S

2

3

1

2

2

SC/S

3

4

1

2

2

SC/S

8 d

1

4

**

2

2

SC/S /ST

2

3

**

2

2

SC/S

3

3

1

2

2

SC/S /ST

S: suppuration

sp: sclera bulging

SC: scar

ST: staphyloma

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of this study, the test substance homoveratrylamine showed irreversible effects on the eyes.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The test substance was applied to the skin of rabbits with an occlusive covering for 4 hours (equivalent to OECD 404). After 24 hours, moderate erythema and edema were observed in all exposure groups. Mean erythema scores (24-48-72 hours) for the 4 hours was 2.0, respectively. Mean edema scores (24-48-72 hours) 4 hours were 2.0, respectively. The effects were not fully reversible within 8 days. Based on the result of this study, the test substance was highly irritating to skin (1978, reliability score: 2).

Eye irritation:

An eye irritation study in White Vienna rabbits were conducted (according Federal Register 38, No. 187), 0.1 mL undiluted test substance was instilled into the eyes of 3 rabbits (one eye per animal). The adjacent untreated eyes of the same animals served as control. The eyes were not washed out. After 8 day strong corneal opacity and marked chemosis and redness of the conjunctives, as well as scar formation was still present. Based on the results of this study, the test substance showed irreversible effects on the eyes (1978, reliability score: 2).

Justification for classification or non-classification

Based on the results of the skin and eye irritation testing, the test item is classified as skin irritation cat. 2 (H315) and causes serios eye damage cat. 1 (H318) according to Regulation (EC) No 1272/2008 (CLP).