Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with restrictions (No GLP study. Only 2 animals used. Reading at 72 hours was not performed. No information about environmental and housing conditions). Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Reference Type:
secondary source
Title:
Dimethyl phosphonate - CAS No: 868-85-9 - SIDS Initial Assessment Report
Author:
OECD
Year:
2004
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No GLP study. Only 2 animals used. Reading at 72 hours was not performed. No information about environmental and housing conditions
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): dymethyl phosphite
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: individual housing


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: it is not clear if the untreated eye served as control
Amount / concentration applied:
Amount applied: 0.1 mL
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: Draize score


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Reddening of the conjunctiva (grade 2) was observed 1h after treatment; no other  effects. Effects reversible in 5 days

Any other information on results incl. tables

Reading at 72 hours was not performed. The same scores assumed as for 48h time point (worst case).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Thyssen (1978)

In an eye irritation study, 0.1 mL of test substance was instilled into the conjunctival sac of one eye of two male young adult New Zealand White rabbits, with a method similar to OECD guideline 405 with deviations (No GLP study. Only 2 animals used. Reading at 72 hours was not performed. No information about environmental and housing conditions). Animals were observed for 7 days. Irritation was scored according to the method of Draize. Reddening of the conjunctiva (grade 2) was observed 1h after treatment; no other effects were observed. Effects were reversible within 5 days. Based on the study results, it can be concluded that dimethyl phosphonate is not irritating to eyes according to DSD and CLP criteria.