Registration Dossier

Administrative data

Description of key information

The test substance causes serious damage to the eye and was scored positive for skin irritation.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
No details about the test substance
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, D 2740 Bremervörde
- Housing: individual
- Diet (e.g. ad libitum): Certified diet (periodically analysed for contaminations)
- Water (e.g. ad libitum): tap water (periodically analysed for contaminations)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin area of the same animal served as control
Amount / concentration applied:
0.5 ml of the test substance applied to ca. 6 cm² test site
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3
Details on study design:
Examination time points: 0-60min, 24 h, 48 h, 72 h after patch removal and thereafter once daily up to day 15. Scoring system as described in OECD 404.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: the end of observation period (day 15).: score 1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: At the end of observation period (day 15): score 1 for 2 out of 3 rabbits
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substacne is a skin irritant. But effects are not completely reversible within 15 days.

In conclusion, classification as irritating is indicated according to Regulation (EC) No 1272/2008: H315 - Causes skin irritation.
Executive summary:

The test was performed according to OECD guideline 404. Three New Zealand rabbits were used; 0.5 ml of the undiluted test substance were applied to the skin; semiocclusive, 4 h exposure; post exposure observation period 15 days. The average score (24-72h) for erythema and edema was 1.2 and 1.3 respectively. The effects for edema was not fully reversible after 15 d.

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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(Version Feb. 1987)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: Little Russian
Details on test animals or tissues and environmental conditions:
Source: BI Phrama KG, D88397 Biberach
Sex: female
Age/weight at study initiation: 2.9 kg
Housing: individual housing
Certified diet and tape water (periodically analysed for contaminations).


Photoperiod (hrs dark / hrs light): 12 h light and 12 h darkness,
Relative humidity: 40-70%,
Temperature: 17-23°C
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
Up to 28 days
Number of animals or in vitro replicates:
1
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: Cornea opacity score (7d - 28 d): 4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 4
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
other: 7 d - 28 d
Score:
>= 2 - <= 3
Reversibility:
not reversible

Cornea Serious damage, not reversible

Iris Score 1 but scoring not possible at some readings

Conjunctiva

Redness Highest scores observed at several readings

Chemosis Highest scores observed at several readings

Discharge Highest scores observed at several readings, not reversible

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test substance causes serious damage to the eye which was not reversible.
Classification as eye damaging is indicated according to Regulation (EC) No 1272/2008: H318 - Causes serious eye damage.
Executive summary:

In a test according to OECD guideline 405 the eye irritating portential of the test item was determined. 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of one female rabbit. Readings were performed at 1, 24, 48, 72 h, 7 days, 14 days, 21 days, and 28 days after instillation. The test substance causes serious damage to the eye which was not reversible.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on these data, the substance is considered to be classified for skin irritation (Cat. 2, H315) and eye damage (Cat. 1, H318) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.