Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The substance is not irritating to skin of rabbits, but irritating to the eyes of rabbits.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The substance was applied (90% in water) in the form of a paste for 1, 5, 15 minutes or 20 hours to the rabbit skin on the back.
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
other: untreated skin of same animal
Amount / concentration applied:
90% in water in the form of a paste (amount not specified)
Duration of treatment / exposure:
1 minute, 5 minutes, 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
5 in total; substance has been applied on the skin of the back of all 5 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: concentrated Lutrol and 50% lutrol
- Time after start of exposure: see duration of exposure; 1 minute, 5 minutes, 15 minutes and 20 hours
Irritation parameter:
edema score
Remarks:
(1, 5 and 15 minutes of exposure)
Basis:
mean
Time point:
other: 24 hours and 8 days
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
(1, 5 and 15 minutes of exposure)
Basis:
mean
Time point:
other: 24 hours and 8 days
Score:
0
Max. score:
4
Irritation parameter:
other: observations regarding skin irritation in case of 20 hours exposure
Basis:
mean
Remarks on result:
other: Slight erythema with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized); fallen off at 8 days.
Irritant / corrosive response data:
The application for 1, 5 or 15 minutes on the back led to no findings within 8 days. After application for 20 hours, on the back, slight erythema was recorded with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized; fallen off) were recorded at day 8 of the observation period.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The test substance was applied as powder (0.1 g) into the right eyes of 2 rabbits, the left eye was treated with physiological saline solution for comparison. The observation period was 10 days.
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: saline-treated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no
Irritation parameter:
other: observations regarding eye irritation
Basis:
other: observations in individual animals
Remarks on result:
other: Findings: on day of treatment: redness and discharge in 2/2; day 2: redness in 1/2, discharge and slight opacity in 1/2; day 3: redness and chemosis in 1/2; day 6: complete reversibility
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (90% in water in the form of a paste) for 1, 5, 15 minutes or 20 hours to the rabbit skin on the back under occlusive conditions (BASF, VIII/56, 1958). The application for 1, 5 or 15 minutes on the back led to no findings within 8 days. After application for 20 hours, on the back, slight erythema was recorded with individual hemorrhages at 24 hours. Circumscribed crusts (lentil-sized; fallen off) were recorded at day 8 of the observation period. Assessment according to current criteria considering 4-hours exposure led to the classification "not irritating".


Eye irritation 
In a non-GLP study according to a method comparable to OECD guideline 405, the test substance was applied as powder (0.1 g) into the right eyes of 2 rabbits, the left eye was treated with physiological saline solution for comparison (BASF, VIII/56, 1958). No washing was performed. On the day of treatment redness and discharge in 2 out of 2 animals were recorded, on day 2 redness, discharge and slight opacity were observed in 1 out of 2 animals and on day 3 redness and chemosis were recorded in 1 out of 2 animals. At day 6 complete reversibility was observed. Assessment according to current criteria led to the classification "irritating".
 

Justification for classification or non-classification

Classification, Labelling, 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 available data on eye  irritation/corrosion, the test item is considered to be classified as cat. 2, H319 ("causes serious eye irritation") according to Regulation (EC) No 1272/2008 (CLP).