Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 3 March 1997 to 30 April 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: TSCA 40 CFR 798.1100
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name in study report: Triethyl Phosphonoacetate (CAS #867-13-0)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: ca. 2 months
- Weight at study initiation: 2.0-2.3 kg (m) 2.0-2.3 kg (f)
- Fasting period before study: none
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but conditions not specified
- Humidity (%): no data
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: from 20 March 1997 to 3 April 1997

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal of the trunk
- % coverage: 10 x 15 cm
- Type of wrap if used: the test item was applied on a surgical gauze. Gentle pressure was applied to the gauze to aid in the distribution of the test item over the preparation site. The torso was wrapped with plastic which was secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): between 3.5 and 4.1 mL depending on the weight of the rabbit
- Constant volume or concentration used: no

VEHICLE
not applicable, test item applied undiluted
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 1, 2 and 4 hours post-dosing then once daily for clinical signs and twice daily for mortality. Test sites scored for dermal irritation at 24 hours post-dose and days 7 and 14, using Darize scoring system.
- Frequency of weighing: immediately pre-test, weekly, at death or termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Instances of diarrhoea and few faeces were observed in one animal on days 12 to 14 of the observation period.
Body weight:
No effect
Gross pathology:
No effect
Other findings:
None

Any other information on results incl. tables

No dermal reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 was greater than 2000 mg/kg bw, with no mortality and no significant clinical findings. No classification is required according to the criteria of EU Reg. 1272/2008 or Directive 67/548/EEC.
Executive summary:

In a GLP-compliant acute dermal toxicity study performed similarly to the OECD 402 guideline, New Zealand White Rabbits (5 animals/sex) were dosed dermally with undiluted Triethyl Phosphonoacetate (purity of 98.4%) at 2000 mg/kg body weight. The test material was kept in contact with the skin for 24 hours with an occlusive dressing. Dermal responses were recorded at 24 hours post dose and on days 7 and 14. The rabbits were observed 1, 2 and 4 hours post-dose then once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for mortality. Body weights were recorded immediately pre-test, weekly, at death and at termination in the survivers. All animals were examined for gross pathology.

All animals survived the 2000 mg/kg bw dermal dose. Instances of diarrhoea and few faeces were observed in one animal on days 12 to 14 of the observation period. There were no dermal reactions. Body weight changes and necropsy results were normal. It was concluded that the LD50 is greater than 2000 mg/kg bw.

Therefore under the test conditions, Triethyl Phosphonoacetate is not classified for acute dermal toxicity according to the criteria of the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.