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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (lack of detailed documentation)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
Reference Type:
review article or handbook
Title:
Methanesulfonic acid.
Author:
Shertzer HG
Year:
2001
Bibliographic source:
Patty's Toxicology, 5th edition, Vol 7, Ch. 94: 745-746
Reference Type:
publication
Title:
HPVIS, IUCLID Data Set for Methanesulphonic acid, CAS no. 75-75-2
Author:
US-EPA
Year:
2003
Bibliographic source:
HPV Chemicals Challenge Program OPPT NCIC 201-14249B

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of detailed documentation
Principles of method if other than guideline:
Single administration of 0.1 ml of the test substance was placed in the conjuctival sac of one eye of each of two rabbits. The treated eye of one of the two animals was rinsed with flowing water (initiated 20 to 30 seconds after instillation and continued for one minute). The treated eye of the other animal was kept unwashed. The reaction was then scored periodically for 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methanesulphonic acid
EC Number:
200-898-6
EC Name:
Methanesulphonic acid
Cas Number:
75-75-2
Molecular formula:
CH4O3S
IUPAC Name:
methanesulfonic acid
Details on test material:
- Name of test material (as cited in study report): Methanesulfonic acid

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (anhydrous solution)
Duration of treatment / exposure:
eye of one rabbit was washed out after 20 seconds and eye of another rabbit was not washed out
Observation period (in vivo):
7 days (the reaction was abserved at 10 min, 1h, 2h, 3h, 4h, 24h, 48h, 72h, 4 days, 5 days, 6 days and 7 days)
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with flowing water for 1 minute (only one animal)
- Time after start of exposure: 20 seconds

SCORING SYSTEM: irritation responses were scored (no data on scoring system)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
other: 24-48-72 h
Score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
other: 24-48-72 h
Score:
0
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
washed eye
Time point:
other: 24-48-72 h
Score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
washed eye
Time point:
other: unwashed eye
Score:
0
Reversibility:
other: no effects
Irritant / corrosive response data:
Unwashed eye:
The reaction involved all ocular tissues and occured immediately. The conjunctivae became completely necrotic (white) without evident swelling. The iris was dilated with ragged edges and failed to react to light. The cornea opacified completely within 24 hours.

Washed eye:
The reaction did not differ significantly from that of the unwashed eye.
Other effects:
Each instillation caused excruciating pain.

Any other information on results incl. tables

Irritation scores:

Time

Unwashed eye

Washed eye

Cornea

Iris

Redness

Chemosis

Cornea

Iris

Redness

Chemosis

10 min

2

2

N

0

2

2

N

0

1 h

2

2

N

0

2

2

N

0

2 h

2

2

N

0

4

?

N

0

3 h

2

2

N

0

4

?

N

0

4 h

2

2

N

0

4

?

N

0

24 h

4

?

N

0

4

?

N

0

48 h

4

?

N

0

4

?

N

0D

72 h

4

?

N

0

4

?

N

0D

4 days

4

?

N

0

4

?

N

0D

5 days

4

?

N

0

4

?

N

0D

6 days

4

?

N

0

4

?

N

0D

7 days

4

?

N

0

4

?

N

0D

N: total necrosis

D: discharge

Applicant's summary and conclusion