Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2017
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2017
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
EC Number:
213-485-0
EC Name:
3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Cas Number:
957-68-6
Molecular formula:
C10H12N2O5S
IUPAC Name:
3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Test material form:
solid
Specific details on test material used for the study:
Chemical name: (6R,7R)-3-[(acetyloxy)methyl)]-7-amino-8-oxo-5thia-1-azabicyclo[4.2.0]oct-2-ene-2carboxylic acid
Batch No.: B363198
Appearance: white yellowish, weakly odorous powder
CAS Number: 957-68-6
Retest date: May 2018
Storage conditions: in refrigerator: 5±3 °C, protected from light
pH value: 4

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: S & K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
Hygienic level during the study: good conventional
Justification of strain: The New Zealand white rabbit is one of the standard animals in acute eye irritation study.
Number of animal: 3 males
Age of animals: adult rabbits, 113 weeks old
Body weight range at the beginning of the study: 3276 - 3556 g
Body weight range at the end of the study: 3460 - 3642 g
Acclimatisation time: 19 days in first animal, 20 days in second and third animals

Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: above 10 air exchanges/hour by central air-condition system

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g of the test item was used for the study in undiluted form, as a single dose. The test material was ground to a fine dust.
Duration of treatment / exposure:
The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals with normal eye condition, any with ocular lesions were rejected.
In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.

In the initial test no irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second and third animal.

Topical anesthetics and systemic analgesics:
Approximately sixty minutes prior to test item application systemic analgesics (dose: 0.01 mg/kg) was administered subcutaneously. Approximately five minutes prior to test item application topical ocular anesthetic (dose: one drop) was applied to each eye. The eye of each animal that was not treated with a test item, but which was treated with topical anesthetics, served as a control.

Clinical Observations and Evaluation of Ocular Irritation
The eyes were examined at 1, 24, 48 and 72 hours after the application. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes.
Any clinical signs of toxicity or signs of pain and/or distress were recorded at least twice daily, with a minimum of 6 hours between observations.
It was no humane sacrificing connected with severe eye lesions during the study.

The eye irritation scores were evaluated according to the scoring system by Draize (1979) and OECD 405.

The body weights were recorded at the beginning and at the end of the experiment, as well as before each systemic analgesics.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
One hour after treatment some hyperemic blood vessels (score 1) were observed in all animals. The swelling of the conjunctivae was different from normal (score 1) in animal No.: 2075 and the amount of discharge of the conjunctivae was different from normal (score 1) in all animals.
24 h, 48 h and 72 h after treatment all animals were free of symptoms.
72 hours after the treatment the study was finished.
During the study the control eyes of animals were symptom-free.
Other effects:
Determined physical-chemical properties of the test item did not reveal potential corrosion effects to the eye.
No systemic toxicity was observed on the day of the treatment and during the 3-day observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was observed in all animals on the treatment day at first observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item caused slight conjunctival irritant effects which were fully reversible within 24 hours.
Executive summary:

The test item was applied to the rabbits' eye mucosa according to OECD guideline 405. The test item caused slight conjunctival irritant effects which were fully reversible within 24 hours.

According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.