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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
20-23 June 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethylphenyl 4-hydroxybenzene-1-sulfonate
Cas Number:
1364731-90-7
Molecular formula:
C14H14O4S
IUPAC Name:
2,6-dimethylphenyl 4-hydroxybenzene-1-sulfonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A single dose of 0.1 g of the solid test item was administered to each animal
Duration of treatment / exposure:
The eyes of the test animals were washed out at 1 hour after application of test item.
Observation period (in vivo):
Clinical Observations
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill-health during the study were recorded. At the end of the observation period, each animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol® 40% anaesthesia (see details in 3.2.). Death was verified by checking pupil and corneal reflex and the absence of respiration.
Number of animals or in vitro replicates:
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition and any with ocular lesions were rejected.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
other: Redness
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hrs

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is therefore not irritant to eyes
Executive summary:

The acute eye irritation has been assessed by application to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP. Following exposure of 1 hour, the eyes were washed, eye reactions were recorded 1, 24, 48 and 72 h after exposure. All effects to the eyes were completelt reversible within 48 hours. The substance is therefore not irritant to eyes.