Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No precision was indicated in the study report concerning the guideline followed
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

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): Triisopropyl phosphite
- Sample number: 2090811
- Density: 0.90 g/mL

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
IN-LIFE DATES: From04-02-1982 to 24-02-1982

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunck
- Type of wrap if used: occlusive rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wet with physiological saline
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg

VEHICLE: No vehicle
Duration of exposure:
24 hours
Doses:
2 g/kg
No. of animals per sex per dose:
3 male and 3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
+ Clinical observations: frequently on the day of treatment and the daily until the end of the study.
+ Assessment for irritation: 24h, 72h, D7, 10 and 14.
+ weighing: D0, 7 and 7

- Necropsy of survivors performed: no
Statistics:
No

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Mortality:
No death during the study
Clinical signs:
No clinicals sign observed
Body weight:
All anaimals gained wieght during the test.
Gross pathology:
No

Any other information on results incl. tables

 

Animal

Sex

D0 BW (kg)

Volume of dosing (mL)

D7 BW (kg)

D14 BW (kg)

Skin irritation

Day 1

Day 3

Day 7

Day 10

Day 14

Erytema

Edema

Erytema

Edema

Erytema

Edema

Erytema

Edema

Erytema

Edema

242 (A)

M

2.6

5.4

2.8

3.1

1

0

1

1

1

1

1

1

0

0

244 (A)

M

2.7

5.9

2.7

2.8

1

0

1

0

1

0

1

0

0

0

281 (A)

F

2.6

5.4

2.7

3.0

1

2

1

2

1

1

1

0

0

0

248 (I)

M

2.6

5.4

2.7

2.9

2

2

1

2

1

1

1

0

0

0

284 (I)

F

2.4

5.2

2.6

2.8

2

2

2

2

1

1

1

0

1

0

282 (I)

F

2.4

5.2

2.6

2.7

2

2

1

2

1

1

1

0

0

0

(A) Abraded

(I) Intact

(BW): Body Weight

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The dermal LD50 of the test material is judged greater than 2.0 g/kg.
Executive summary:

The liquid test material was administered at a dose level of 2.0 g/kg to three male and 3 female New Zeland White rabbit. The hair was clipped from the entire trunk of each animal prior treatment. The skin, on three animalss ( 2 male 1 female) was abraded while the skin on the remaining three animals was left intact. Gauze and occlusive rubber dam covered the trunks of each animal. Immediately after treatment the animals were fitted with Elizabethan collars to restrcit contact with the test site. The animals were observed for signs of toxicity frequently on the day of treatment and daily thereafter for 14 days. After the initial 24 hours, the rabbits were unwrapped and the test sites wiped with cotton wet with physiological saline. The areas of application were assessed for irritation at 24 jourand 72 hours, 7, 10 and 14 days after treatment. After 14 days, the surviving animals were killed and discarded. There were no deaths after administration of the test compound. All animals gained weight throughout the study. There were no toxic signs observed in any of the animals during the study. All animals appeared normal.

The test material elicited signs of slight irritation in all rabbit. By day 14, there was barely perceptible irritation in one animal; all others were without irritation. There was flaking skin obseed on the tests sites of all animals on day 14.