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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-08-11 to 1987-08-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study reliable without restrictions GLP certificate is missing. The study was conducted before compulsory of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 February 1987
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hydrogensulphate
EC Number:
231-665-7
EC Name:
Sodium hydrogensulphate
Cas Number:
7681-38-1
Molecular formula:
H2O4S.Na
IUPAC Name:
sodium hydrogen sulfate
Details on test material:
- Name of test material (as cited in study report): Sodium hydrogen sulphate
- Physical state: pale yellow, pearly product
- Analytical purity: 95 % NaHSO4
- Composition of test material, percentage of components: 95 % NaHSO4; 5 % Na2SO4
- Batch No.: AZBG 015
- Storage condition of test material: in the dark at 22 °C in the extractor hood
No further information on test material was stated.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 3.2 kg
- Housing: individually in accclimatised rooms
- Diet (ad libitum): Altromin 2123 Haltungsdiät - rabbit, Altromin -GmbH, Lage/Lippe; in addition hay (ca. 15 g daily)
- Water (ad libitum): deionised, chlorinated water

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Relative humidity: 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 /12
No further information on test animals was stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg sodium hydrogen sulphate
No further information was stated
Duration of treatment / exposure:
not stated
Observation period (in vivo):
examination at 1, 24 and 48 hours
Number of animals or in vitro replicates:
1 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 24 hours after application of the test substanceas as well as at other observation times at which the eye showed discharge or at which the corneal examination was conducted a fluorescein sodium solution. For the washing a physiological saline was used.
SCORING SYSTEM:
Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
No further information was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: it was not reversable in 48 h.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: It was not reversable within 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: It was not reversable within 48 h.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: It was reversable within 24 h.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: It was not possible to rate the erythema for 24 h and 48 since the conjunctivae was stained.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: It was not reversable within 48 h.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: It was not reversable within 48 h.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: It was not reversable within 48 h.
Other effects:
24 h and 48 h: clear colourless to white mucous discharge.
48h post application experiment was terminated due to the severe irritation.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is classified as serious eye irritant (R41).
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 1.