1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine

Eye irritation

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: Prior to GLP, but standard procedure well described.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize

GLP compliance:

no

Remarks:

prior to GLP guidelines

Test material

Test material information

Constituent 1

Reference substance name:

GM102E

IUPAC Name:

GM102E

Details on test material:

Nature of substance: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ditta Attilio Sala, Milano, It.
- Age at study initiation: no data
- Weight at study initiation: 2000 g
- Housing: individual macrolon cages
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: > or = 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3
- Humidity (%): 60% +/- 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 11 hours light

IN-LIFE DATES: From: 31 May 1983 To: 1 June 1983

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):

Intended: 1 min, 1, 2, 4 24, 48, 72 hours, day 4 and day 7.

Number of animals or in vitro replicates:

9 intially intended. Due to severe irritation observed in the first 2 animals, the study was terminated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): intended in 3 out of the 9 animals. Only one animal was eventually tested with rinse out, due to severe effects observed..
- Time after start of exposure: 30 seconds following application

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1 and #2

Time point:

other: From 2 hours after instillation

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks:

study terminated after 24 hours due to severe effects

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 3

Results 2

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

other: From 24 hours after instillation

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

study terminated after 24 hours due to severe effects

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #2

Time point:

other: From 24 hours after instillation

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

study terminated after 24 hours due to severe effects

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 4

Results 4

Irritation parameter:

iris score

Basis:

animal: #1 and #2

Time point:

other: From 2 hours after instillation

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks:

study terminated after 24 hours due to severe effects

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 2. [missing part of the results, most likely score 2 at 2 hours and beyond]

Irritant / corrosive response data:

Reversibility of any observed effect: Changes not fully reversible within 1 day
The study was terminated after 24 hours following observations of severe effects in 2 rabbits. No further animals were treated.

Other effects:

The ocular lesions reached the maximum for each paramater within 24 h after the administration of the substance. The lesions caused severe damage to the eyes and the animals were humanly sacrificed due to poor conditions.
Rinsing the eyes within 30 seconds after application (1 animal) did not produce significant changes in the severity of the effects.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Severe ocular effects were observed within 2 to 24 hours after treatment. The study was terminated.

Executive summary:

The eye irritant potential of the test item GM102E was investigated in a test performed on New Zealand White rabbits according to the Draize method. 

100 mg of test item was applied during 30 secondes before washing. The effects were intended to be observed during 7 days after application.

The study was terminated after 24 hours following observations of severe effects in 2 rabbits. No further animals were treated.

The ocular lesions reached the maximum for each parameter within 24 h after the administration of the substance. The lesions caused severe damage to the eyes and the animals were humanly sacrificed due to poor conditions.

Rinsing the eyes within 30 seconds after application (1 animal) did not produce significant changes in the severity of the effects.

Based on these results and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), GM102E should be classified for serious eye damage (Eye dam. Category 1, H318).