N-(carboxymethyl)-N-(phosphonomethyl)glycine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 30 - July 7, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with FIFRA and OPPTS/OTS guidelines, however there are some basic differences (scoring system and observation period) with current OECD TG, no GLP followed

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: TSCA: Health Effects Test Guidelines; OTS; OPTS; USEPA 1982, Acute Exposure, Primary dermal irritation and Federal register, 1979, Part 772.112-25

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(carboxymethyl)-N-(phosphonomethyl)glycine

EC Number:

227-824-5

EC Name:

N-(carboxymethyl)-N-(phosphonomethyl)glycine

Cas Number:

5994-61-6

Molecular formula:

C5H10NO7P

IUPAC Name:

2-[(carboxymethyl)(phosphonomethyl)amino]acetic acid

Details on test material:

- Name of test material (as cited in study report): Glyphosate Intermediate
- Physical state: White powder
- Analytical purity: 98.05%
- Lot/batch No.: 4-86-587
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton-Dutchland Inc., Denver, Pennsylvania
- Age at study initiation: young adults
- Housing: Individually housed in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Lab Chow 5326
- Water (e.g. ad libitum): Municipal Water Supply
- Acclimation period: 34 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-27°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: June 30, 1986 To: July 7, 1986

Test system

Type of coverage:

other: both semi-occlusive and occlusive conditions

Preparation of test site:

other: clipped

Vehicle:

physiological saline

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per site

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hour (two sites) and 24 hour (two sites)

Observation period:

3-7 days

Number of animals:

Six (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: Clipped dorsal area, near to the head for 4 hour exposure. For 24 hour exposure, sites posterior to the 4-hour sites were used.
- % coverage: 10% of body surface area
- Type of wrap if used:
4 hour exposure: 1 x 1" gauze, appropriate amount of the test material was applied to the gauze and held with non-irritating tapes and then wrapped with porous tape for semi-occlusion.

24-hour exposure: 1 x 1" gauze, appropriate amount of the test material was applied to the gauze and held with non-irritating tapes and then wrapped with plastic sheet for occlusion.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was wiped off the site after the exposure periods.
- Time after start of exposure: 4 hour and 24 hour


SCORING SYSTEM: Method of Draize JH (1959) was followed for scoring and modified method presented in Federal Hazardous Substances Act Regulations, 16 CFR, 1500 was followed for calculation of primary dermal irritation index.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.22

Max. score:

8

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Glyphosate intermediate essentially produced no signs of irritation at both 4 hour and 24 hour exposure sites. The only irritation seen in some animals was very slight, barely perceptible, erythema which subsided within 2 to 7 days. No tissue destruction was observed.

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, glyphosate intermediate, was considered to be not irritating to skin.

Executive summary:

A study was conducted to determine the primary skin irritation potential of glyphosate Intermediate in rabbits according to EPA OPP 81-5 (Acute Dermal Irritation) guideline and TSCA: Health Effects Test Guidelines, USEPA 1982, Acute Exposure, Primary dermal irritation and Federal register, 1979, Part 772.112-25.

Groups of three male and female New Zealand White rabbits were exposed to the undiluted test material through semi-occlusive coverage for 4 hours and occlusive coverage for 24 hours. The treated sites were observed approximately 24, 48 and 72 hours after removal of coverage.

Glyphosate intermediate essentially produced no signs of irritation at both 4 hour and 24 hour exposure sites. The only irritation seen in some animals was very slight, barely perceptible, erythema which subsided within 2 to 7 days. No tissue destruction was observed. The primary dermal irritation index for the 24 hours exposure was calculated to be 0.22.

Based on the results, the test material, glyphosate intermediate, was considered to be not irritating to skin.