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Diss Factsheets

Administrative data

Description of key information

- skin: corrosive (rabbit; 1988; Bomhard, 1997) 
- eye: severe damage to eyes (rabbit; Bomhard, 1997)
- respiratory: irritation to respiratory tract cannot be excluded.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
xposure period was not 4 hours, but the test substance is corrosive
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(animals were used for a 3 minutes and 1 hour exposure; exposure period was not 4 hours, but the test substance is corrosive)
GLP compliance:
not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany (female rabbit) and Savo, med. Versuchstierzuchten, Kissling/Germany (males)
- Weight at study initiation: 2.77 kg (female), 2.3 kg (males)
- Housing: singly
- Diet: Kliba 341, about 130 g/animal/day
- Water: tap water, about 250 mL/animal/day
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
3 minutes (right flank) and 1 hour (left flank)
Observation period:
72 hours
Number of animals:
1 female and 2 male animals
Details on study design:
TEST SITE
Clipping of the fur: at least 15 hours before the beginning of the study.
- Area of exposure: 2.5 x 2.5 cm, upper third of the back or flanks

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period

SCORING SYSTEM:
based on J .H . Draize: Appraisal of the safety of chmemicals in foods, drugs and cosmetics. In dermal toxicity pp. 46 - 59, 1959 Austin, TEX.
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 3 minutes exposure
Remarks on result:
other: superficial/medium thickness scabbing was observed but no necrosis
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 1 hour exposure
Reversibility:
not reversible
Remarks on result:
other: necrosis was observed immediately after exposure and during the whole observation period; full thickness necrosis was confirmed 72 hours after exposure at gross pathology
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 hours post treatment
Score:
3
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 3 minutes exposure; Erythema extending beyond the area of exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 hours post treatment
Score:
1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 3 minutes exposure; Edema extending beyond the area of exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 hours post treatment
Score:
3.7
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 hours post treatment
Score:
1.7
Max. score:
4
Reversibility:
no data
Remarks on result:
other: 1 hour exposure; Edema extending beyond the area of exposure
Irritant / corrosive response data:
3 minutes exposure:
Edema and erythema extending beyond the area of exposure and hemorrhage was observed in the male animals up to 24 hours after exposure. Superficial scabbing/medium thickness scabbing was additionally observed 72 hours post exposure in the male test animals.
1 hour exposure:
Edema extending beyond the area of exposure was observed in all test animals at any time post exposure. Necrosis was observed one hour after exposure up to 48 hours, resulting in full thickness necrosis after 72 hours in the male animals and superficial scabbing in the female animal. Findings were confirmed by gross pathology examination.

Table 1: Erythema and Edema scores of animals treated for 3 minutes with the unchanged test substance

Observation time

Animal

Erythema

Edema

 Add. information

3 minutes

1

2

0

 

 

2

2

2

 Edema and erythema extending beyond the area of exposure

 

3

4

0

 hemorrhage

24 hours

1

2

0

 

 

2

3

1

 Edema and erythema extending beyond the area of exposure

 

3

4

2

 hemorrhage

48 hours

1

3

0

 

 

2

4

1

 

 

3

3

2

 

72 hours

1

2

0

 

 

2

3

1

 Superficial scabbing

 

3

3

2

 Medium thickness scabbing

 Mean

 1

2.3

0

 

 

 2

3.3

1

 

 

 3

3.3

2

 

 Mean

 

3

1

 

Table 2: Erythema and Edema scores of animals treated for 1 hour with the unchanged test substance

Observation time

Animal

Erythema

Edema

Add. information

1 hour

1

3

1

 Edema extending beyond the area of exposure

 

2

4

3

Necrosis; Edema extending beyond the area of exposure

 

3

4

3

 Necrosis; Edema extending beyond the area of exposure

24 hours

1

3

2

Edema extending beyond the area of exposure

 

2

4

2

 Necrosis; Edema extending beyond the area of exposure

 

3

4

2

Necrosis; Edema extending beyond the area of exposure

48 hours

1

3

1

 Edema extending beyond the area of exposure

 

2

4

2

Necrosis; Edema extending beyond the area of exposure

 

3

4

2

 Necrosis; Edema extending beyond the area of exposure

72 hours

1

3

1

Superficial scabbing; Edema extending beyond the area of exposure

 

2

4

2

 Full thickness necrosis; Edema extending beyond the area of exposure

 

3

4

1

Full thickness necrosis; Edema extending beyond the area of exposure

 Mean

 1

3

1.3

 

 

 2

4

2

 

 

 3

4

1.7

 

 Mean

 

3.7

1.7

 

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
no data on test substance purity
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.1 - 3.4 kg
No further information.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with physiologic saline
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize; the irritation indices were calculated in accordance with Guideline 83/467/EC No. 8

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
After 7 d the nictitating membrane and the palpebral conjunctiva showed necrotic changes. Therefore, the test substance was found to cause severe damage to the eyes.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In a study (1988, reliability score 2) conducted according to OECD 404, the potential of the test substance to cause acute dermal irritation or corrosion was assessed by single topical application of 0.5 mL unchanged test substance for 4 hours to the intact skin of 1 male Vienna White rabbit using a test patch of 2.5 x 2.5 cm, covered with a semiocclusive dressing. The cutaneous reactions were assessed 24, 48 and 72 hours after removal of the patch. Mean 24-48-72-hour scores were 4 (max. 4) and 2 (max. 4) for erythema and edema, respectively. Necrosis was firstly observed 4 hours after application. Erythema extending beyond the area of exposure and necrosis was observed after termination of exposure. The effects were not reversible. At pathology, full thickness necrosis was confirmed.

In a second study (1988, reliability score 2) the potential of the test substance to cause corrosion was assessed by single topical application of 0.5 mL unchanged test substance for 3 minutes and 1 hour, respectively, to the shaved skin of 1 male and 2 female Vienna White rabbits using a test patch of 2.5 x 2.5 cm, covered with a semiocclusive dressing. The cutaneous reactions were assessed 24, 48 and 72 hours after removal of the patch. Mean 24-48-72-hour scores were 3 and 3.7 (3 min and 1 h exposure) and 1 and 1.7 (3 min and 1 h exposure) for erythema and edema, respectively. Erythema (3 min exposure) and edema (3 min and 1 h exposure) extended beyond the area of exposure. After 3 min exposure superficial/medium thickness scabbing was observed but no necrosis. After 1 h exposure necrosis was observed immediately after exposure and during the whole observation period; full thickness necrosis was confirmed 72 hours after exposure at gross pathology.

Additionally, there is a publication from Bomhard E. et al. (1997, reliability score 4) which is not assignable, because only short method and result descriptions were available, but supports the results of the described studies.

 

Eye Irritation

There is one study concerning eye irritation available which confirmed the corrosive potential of the test substance (Bomhard E. et al., 1997, reliability score 2). A dose of 100μL was administered into one eye of three young adult female New Zealand White rabbits for an exposure period of 24 hours. Then the treated eyes were rinsed with physiologic saline. The eyes were examined and the grade of ocular reaction was recorded at 1, 24, 48 and 72 hours and again on day 7 according to Draize. Mean irritation scores at the 24, 48 and 72 hour readings were 3.0 for corneal opacity. 1.0 for iritis, 3.0 for conjunctival redness and swelling. At 7 d the nictitating membrane and the palpebral conjunctiva showed necrotic changes. Therefore the test substance was found to cause severe damage to eyes.

 

Respiratory irritation

In an inhalation hazard test (1989, reliability score 2) irritating effects to the eyes and the respiratory tract (accelerated/intermittent respiration, eyelid closure, wiping of snouts, salivation, nasal discharge, reddish nasal/eye discharge) were observed during exposure of rats to a test atmosphere saturated with vapours of the test substance for 7 hours. Additionally, based on the available data on skin corrosivity and severe damage to eyes irritation to the respiratory tract cannot be excluded.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, the test substance has to be classified as irritating to respiratory tract (STOT SE 3), causing risk of serious damage to eyes (Eye Dam. 1) and corrosivity to the skin (Skin Corr. 1B).