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Diss Factsheets

Administrative data

Description of key information

A study according to OECD guideline 404 and one study according to OECD guideline 405 were conducted. The test substance was not irritating to the skin and to the eyes of rabbits.
- skin: not irritating (OECD 404)
- eyes: not irritating (OECD 405)

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Physical state: powder / grey-white
- Analytical purity: 95.8% (per weight; HPLC)
- Lot/batch No.: ZD 1151/ 31 (production: 03-Dec-1997)
- Storage condition of test material: refrigerator, protected from light.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG / Chbb: NZW (SPF)
- Age at study initiation: young adult animais
- Weight at study initiation: 4.00 and 3.98 kg for the 2 females, 3.92 kg for the male
- Housing: The animals were single-housed in fully air-conditioned rooms in Stainless steel wire mesh cages with grating, floor area: 3000 cm2; animal identification: ear tattoo. No bedding in the cages; wood shavings in the waste trays.
- Diet, ad libitum: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, (about 130 g per animal per day). The feed used in the study was assayed for chemical and microbiological contaminants. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Water, ad libitum: about 250 ml tap water per animal per day. The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Central air-conditioning guaranteed a range of 20 - 24 degrees
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 hours (6.00 am - 600 pm/ 6.00 pm - 6.00 am)
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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3 (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: At least 24 hours before the test, the fur was removed, by clipping the dorsal part of the trunk of the animals (upper third of the back or flanks.). Only animals with healthy intact skin have been used. The test patch (2.5 cm x 2.5 cm) was covered with unchanged solid test substance moistened with aqua bidest (because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible).
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing; test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Polyethylenglycol DAB (BASF Aktiengesellschaft) and Polyethylenglycol DAB/water (1:1).
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline no. 404 (adopted July 17, 1992) and EEC directive 92/69, L 383A, B.4 (December 29, 1992).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all treated animals
Time point:
other: 1-24-48-72 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no erythema was observed
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all treated animals
Time point:
other: 1-24-48-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema was observed
Irritant / corrosive response data:
Under the test conditions chosen and considering the described findings LC 242 does not give indication of an irritant property to the skin. The test substance is therefore considered not irritating according to the EU and to GHS
Other effects:
No other effects were observed
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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Physical state: powder / grey-white
- Analytical purity: 95.8% (per weight; HPLC)
- Lot/batch No.: ZD 1151/ 31 (production: 03-Dec-1997)
- Storage condition of test material: refrigerator, protected from light.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG / Chbb: NZW (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: 3.51 and 3.72 kg for the 2 females, 3.58 kg for the male
- Housing: The animals were single-housed in fully air-conditioned rooms in Stainless steel wire mesh cages with grating, floor area: 3000 cm2; animal identification: ear tattoo. No bedding in the cages; wood shavings in the waste trays.
- Diet, ad libitum: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, (about 130 g per animal per day). The feed used in the study was assayed for chemical and microbiological contaminants. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Water, ad libitum: about 250 ml tap water per animal per day. The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Central air-conditioning guaranteed a range of 20 - 24 degrees
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 hours (6.00 am - 600 pm/ 6.00 pm - 6.00 am)
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 30 mg of the comminuted test substance)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
up to 28 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD guideline 405 (adopted February 24, 1987) and EEC directive 92/69, L 383A, B.5 (December 29, 1992).
Irritation parameter:
cornea opacity score
Remarks:
cornea opacity
Basis:
mean
Remarks:
from animal #1 and animal #3 (all female)
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
cornea opacity
Basis:
animal #2
Remarks:
male
Time point:
other: 24-48-72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 28 days
Remarks on result:
other: observed from 48 hours after treatment
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
from animal #1, #2 and #3
Time point:
other: 24-48-72 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 28 days
Remarks on result:
other: positive response observed in one treated animal
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1 and animal #3
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: observed from 24 hours after treatment
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24-48-72 hours
Score:
0.2
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: positive response observed in only one treated animal
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animals #1 and 2
Time point:
other: 24-48-72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: scores after 1 hour: 1/2 (animal #1/animal #2); 24 hours: 2/2; 48 hours: 1/1; 72 hours: 1/1; 7 days: 0/1; and 14 days: 0/0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24-48-72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: scores after 1 hour: 1; 24 hours: 2; and 48 hours: 0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
from animals #1, #2 and #3
Time point:
other: 24-48-72 hours
Score:
1.1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: scores (animal #1/animal #2/animal #3) observed after 1 hour: 1/1/1; 24 hours: 0/2/1; 48 hours: 0/1/0; 72 hours: 0/1/0; and 7 days: 0/0/0;
Other effects:
conjunctiva discharge was observed in animal #3 after 24 hours (score: 1) and in animal #2 after 1 hour (1), 24 hours (2), 48 hours (1) and 72 hours (1). No other adverse effects were observed

One animal still had corneal opacity grade 1 after 21 days but was free of symptoms after 28 days. The other 2/3 animals were free of symptoms after 7 days and did not show any corneal opacity at any time.

Interpretation of results:
GHS criteria not met
Conclusions:
One animal still had corneal opacity grade 1 after 21 days but was free of symptoms after 28 days. The other 2/3 animals were free of symptoms after 7 days and did not show any corneal opacity at any time.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

A study in accordance with OECD guideline 404 with 3 rabbits demonstrated no irritation potential of the test material. Both the mean erythema as well as the edema value of scores of the 24 -72 h time points were zero.

A study in accordance with OECD guideline 405 with 3 rabbits revealed no irritation potential of the test substance. The mean value of the conjunctival redness score was 1.3, the mean value of scores for iritis was 0.2. Both were reversible within 72 hours. Corneal opacity was observed in one of the animals which was not reversible within the 21 day observation period.

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 1272/2008. A GLP-compliant OECD 404 study is available for skin irritation. A GLP-compliant OECD 405 is available for eye irritation. In both studies, the mean scores for the test item treated tissues were below the thresholds for classification as an irritant.

In case of the eye irritation study, 1 of 3 animals still had corneal opacity grade 1 after 21 days but was free of symptoms after 28 days. The other two animals were free of symptoms after 7 days and did not show any corneal opacity at any time. According the EC 1272/2008, findings that have not fully reversed "within normally 21 days" should result in a classification. In this case, full reversibility was observed within 28 days. A classification for irreversible damage is therefore not applicable.

As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.