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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; 50 mm3 (one sharp-edged spoon) of test material applied (OECD0.1 ml,< 100 mg); 4 animals were used (OECD: 3); the eyes were not washed out after 24 h (OECD: washing after 24 h); observation period was 8 days (OECD: 21)
Principles of method if other than guideline:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 µl or one sharp-edged spoon in case of solids of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydroxylammonium chloride
EC Number:
226-798-2
EC Name:
Hydroxylammonium chloride
Cas Number:
5470-11-1
Molecular formula:
ClH.H3NO
IUPAC Name:
hydroxyammonium chloride
Details on test material:
- Name of test material (as cited in study report): Hydroxylammoniumchlorid techn. rein
- Analytical purity: 99 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: animal 1: 3.11 kg; animal 2: 2.7 kg; animal 3: 3.34 kg; animal 4: 2.92 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of the same rabbit was treated with 50 mg talcum powder.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: one sharp-edged spoon of the test substance, undiluted; ca. 50 mg
Duration of treatment / exposure:
24 h; the substance was not washed out.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2 males and 2 females
Details on study design:
One sharp-edged spoon (ca. 50 mg) of the undiluted, solid test substance was applied to the right conjuntival sac of one male and one female Vienna White rabbit. The left eye, treated withtalcum powder, served as a control. The substance was not washed out.
Ocular reactions were recorded after 10 min, 1, 3, 24, 48 and 72 hours, as well as 6 and 8 days after instillation in 2/4 animals or alternatively after 10 min, 1, 3, 24 and 48 hours, as well as 5, 6 and 9 days after instillation in the remaining two animals using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation the BASF scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours (animal 1 and 3) and 24, 48 hours after application (animal 2 and 4), respectively.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24-48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.66
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24-48 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24-48 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24-48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test item causes serious eye damage/irritation.
Executive summary:

Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. The test substance was applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control.Talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. 


Severe eye irritation effects were seen in the treated eyes of the animals, including the occurence of staphyloma in two cases. The effects observed were in some cases not fully reversible at the end of the observation period after 8 days.