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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ditta Attilio Sala, Milano
- 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/day

IN-LIFE DATES: From: 31-May-1983 To: 03-June-1983

Test system

Type of coverage:

occlusive

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 mg
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

8 h

Observation period:

3 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal area
- % coverage:
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

for the intact skin sites

Basis:

mean

Remarks:

for the 6 animals and 3 time points

Time point:

other: 24-48-72 hours

Score:

0.4

Max. score:

1

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: Max. duration: 72 hrs; Max. value at end of observation period: 0

Results 2

Irritation parameter:

edema score

Remarks:

for the intact skin sites

Basis:

mean

Remarks:

Mean for the 6 animals and 3 time points

Time point:

other: 24-48-72h

Score:

0

Max. score:

0

Remarks on result:

other: Max. duration: 3days; Max. value at end of observation period: 0

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

other: Draize scoring

Time point:

other: 24 hours (highest value)

Score:

0.7

Max. score:

8

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: practically non-irritating

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 3 days

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information CLP criteria REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU

Conclusions:

The test material produced only minimal transient irritation.

Executive summary:

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

200 mg of test item was applied during 8 hours on the dorsal area of 6 animals with an occlusive coverage. The effects were observed during 3 days after application.

Very slight erythema reactions were observed on several rabbits but these reactions were reversible within the end of the observation period (3 days). Thus the substance is considered as a very slight skin irritant.

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 not be classified for skin irritation.