Registration Dossier

Administrative data

Description of key information

According to a study on skin irritation (OECD 404 & GLP) the test item is considered to be not irritating to rabbit skin (BASF, 18H0059/952020, 1995).
Based on an eye irritation study (OECD 405 & GLP), the test item is not irritating to rabbits eyes (BASF SE, 11H0059/952021, 1995).

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)
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animal species: rabbit / White New Zealand (SPF)
Animal supplier: dr. K. Thomae GmbH, Biberach, Germany
Age of the animals: young adult animals
Animal identification: ear tattoo
Room temperature/ Relative humidity: the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 -24 degrees Celsius for temperature and of 30 -70 % for relative humidity. There were no deviations from these ranges which influenced the results of the study.
Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
Type of cage: stainless steel wire mesh cages with grating,
No. of animals per cage: single housing
Bedding: no bedding in the cages; sawdust in the waste trays
Drinking water: about 250 ml tap water per animal per day
Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day).

Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in tue study was assayed for chemical and microbiological contaminants.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: undiluted, but test patch was moistened with aqua bidest.
Duration of treatment / exposure:
4 h
Observation period:
72 hours (1 animal); 15 days (2 animals)
Number of animals:
3
Details on study design:
Application site:
Upper third of the back or flanks

Number of animal(s) /animal weight(s) at the beginning of the study:
Animal: 01 / 02 / 03
Weight (kg): 3.13 / 3.28 / 3.47
Sex: male / male/ female


Observation period:
72 h animal 01
15 d animal 02 and 03

Readings:
1 h, 24 h, 48 h, 72 h, 8 d and 15 d after removal of the pach.

General observations:
A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.


TEST SITE
- Area of exposure: clipped dorsal area ofthe trunk, 2.5 cm x 2.5 cm
- Type of wrap if used: semioccluive

REMOVAL OF TEST SUBSTANCE
- Washing: yes, washing with Lutrol and Lutrol:water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM:
OECD Draize Schema (nach Grundler, 1983)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: mechanical skin lesions due to adhesive test substance
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Remarks on result:
other: mechanical skin lesions due to adhesive test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
4

 Readings  Animal  Erythema  Edema  Symptoms
 1 hour  1  0  0  
   2  0  0  MSL
   3  3  1  MSL
 24 hours  1  0  0  
   2  2  0  MSL
   3  2  0  MSL
 48 hours  1  0  0  
   2  1  0  MSL
   3  2  0  MSL
 72 hours  1  0  0  Study discontinued because the animal was free of symptoms
   2  1  0  MSL
   3  1  0  MSL
 8 days  2  1  0  MSL
   3  1  0  MSL
 15 days  2  0  0  
   3  1  0  MSL
 MEAN  1  0.0  0.0  
   2  1.3  0.0  
   3  1.7  0.0  
 MEAN  1 -3  1.0  0.0  
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animal species: rabbit / White New Zealand (SPF)
Animal supplier: Dr. K. Thomae GmbH, Biberach, Germany
Age of the animals: young adult animals
Animal identification: ear tattoo
Room temperature/ Relative humidity: the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 -24 °C for temperature and of 30 -70 % for relative humidity. There were no deviations from these ranges which influenced the results of the study.
Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
Type of cage: stainless steel wire mesh cages with grating,
No. of animals per cage: single housing
Bedding: no bedding in the cages; sawdust in the waste trays
Drinking water: about 250 ml tap water per animal per day
Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day).

Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in tue study was assayed for chemical and microbiological contaminants.
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL bulk volume (about 42 mg of the comminuted test substance)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24 h

SCORING SYSTEM:
According to OECD guideline 405
Irritation parameter:
cornea opacity score
Basis:
animal: #1-#3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
other: area of cornea involved
Basis:
animal: #1 - #3
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1 - #3
Time point:
24/48 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
other: discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
other: discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h

 Readings  Animal  Cornea     Iris  Conjunctiva      
     Opacity  Area    Redness  Chemosis  Discharge
               
1 hour   1  0  0  0  2  2  2
   2  0  0  0  2  2  2
   3  0  0  0  2  2  2
 24 hours  1  0  0  0  2  1  1
   2  0  0  0  2  1  1
   3  0  0  0  2  1  1
 48 hours  1  0  0  0  1  0  1
   2  0  0  0  2  1  0
   3  0  0  0  1  0  0
 72 hours  1  0  0  0  1  0  0
   2  0  0  0  1  0  0
   3  0  0  0  1  0  0
 8 days  1  0  0  0  0  0  0
   2  0  0  0  0  0  0
   3  0  0  0  0  0  0
 MEAN  1  0.0    0.0  1.3  0.3  
   2  0.0    0.0  1.7  0.7  
   3  0.0    0.0  1.7  0.4  
 MEAN    0.0    0.0  1.6  0.4  
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A GLP conform in vivo study was performed to assess the acute dermal irritation potential of the test item in white New Zealand rabbits according to the OECD guideline 404 (BASF SE, 1995). An amount of 0.5 g of the test substance (containing 1.64% NaOH) was single topical applied to the intact skin of 3 rabbits for 4 hours under semi-occlusive dressing. Only one of three animals diplayed a mean erythema score >=1.5 which was not fully reversible within 15 days. The other animals showed a mean erythema score lower than 1.5 and their lesions completely regressed. None of the animals displayed oedemas during the observation period. Mechanical skin lesions due to the adhesivity of the test substance could be observed in two of three animals during the observation period. This lesions are most likely caused by the removal of the test substance after the exposure period. Thus, they can not be considered as an adverse effect. In conclusion, under the test conditions chosen, the test item has only marginal skin irritating properties.

 

Eye irritation

To assess the acute eye irritation potential of the test item in vivo, a GLP conform eye irritation test in white New Zealand rabbits was performed according to OECD guideline 405 (BASF SE, 1995). An amount of 42 mg of the test substance (containing 1.64% NaOH)

was single ocular applied to three rabbits. In none of the animals, cornea and iris showed any signs of irritation. The mean chemosis score in all animals was not higher than 0.7 and mean conjuctival redness was maximally scored 1.7. The findings were reversible in all animals within 8 days after application.

 Under the test conditions chosen and considering the present data, the test item does not give indication for eye irritating properties.

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. In vivo studies did not reveal irritating effects neither on skin nor on the eye. As a result the substance is not considered to be classified as skin or eye irritant under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.