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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium sulphamidate
EC Number:
231-871-7
EC Name:
Ammonium sulphamidate
Cas Number:
7773-06-0
Molecular formula:
H3NO3S.H3N
IUPAC Name:
sulfamic acid
Specific details on test material used for the study:
The test substance was Basensol GS, which was composed of 100% ammonium sulphamidate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult rabbits (3.35-3.81 kg each) 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.
Day/night rhythm of 12h/12h. Single housing.
About 250 mL tap water per animal per day and about 130 g diet per animal per day.
Acclimatization for at least 1 week.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL (single application)
Duration of treatment / exposure:
Single application of test substance, which was not washed out.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals (one male and two females).
Details on study design:
Weight determination: shortly before application of the test substance.
Route of application: single application to the conjunctival sac of the right eyelid; the substance was not washed out.
Readings: 1h, 24h, 48h and 72h after application.
General observations: a check was made twice each workday and once saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.2
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions chosen and considering the described findings, Basensol GS does not give indication of an irritant property to the eye.