2-acrylamido-2-methylpropanesulphonic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02/02/1996-16/02/1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study conducted to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt

IUPAC Name:

2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt

Constituent 2

Reference substance name:

Ammonium 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonate

EC Number:

421-680-9

EC Name:

Ammonium 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonate

IUPAC Name:

421-680-9

Constituent 3

Reference substance name:

58374-69-9

EC Number:

611-646-3

Cas Number:

58374-69-9

IUPAC Name:

58374-69-9

Details on test material:

- Name of test material (as cited in study report): OS 114454
- Molecular formula (if other than submission substance): C7H16N2O4S
- Molecular weight (if other than submission substance): 225.29
- Smiles notation (if other than submission substance): [NH4+].O=S(=O)(O)CC(C)(C)/N=C(\[O-])C=C
- InChl (if other than submission substance): 1/C7H13NO4S.H3N/c1-4-6(9)8-7(2,3)5-13(10,11)12;/h4H,1,5H2,2-3H3,(H,8,9)(H,10,11,12);1H3
- Substance type: organic
- Physical state: liquid
- Analytical purity: 50% aqueous solution
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: not specified
- Storage condition of test material: original container at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton Research Products Inc, Denver (PA), USA
- Age at study initiation: Young adult
- Weight at study initiation: 2164- 2512 grams
- Fasting period before study:
- Housing: Individual suspended mesh bottom cages
- Diet: ad libitum)
- Water: ad libitum)
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-20.2°C (67.5-68.4°F)
- Humidity (%): 34.1-54.1%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2/2/1996 To: 16/2/1996

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal skin
- % coverage: approximately 23
- Type of wrap if used: gauze binder with collar

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with deionised water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.45 ml/kg
- Concentration (if solution): 50%
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

4,000 mg/kg test material (2,000 mg/kg active ingredient)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily post-administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

4 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observed.

Clinical signs:

other: Two rabbits had instances of soft stool on days 1 and 6, but this finding was determined not to be related to the test material. There were no other clinical findings. The test material induced very slight to slight erythema on all animals. Three rabbits

Gross pathology:

Upon terminal necropsy, two rabbits displayed accessory splenic tissue, a common congenital abnormality in New -Zealand white rabbits. Dark red lungs were noted in two animals. There were no other remarkable finding.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance (OS 114454) was found to be greater than 2000 mg/kg (based on active ingredient, 4000 mg/kg based on test substance) when administered once for 24 hours to the clipped, intact skin of male and female albino rabbits. In addition, 2000 mg/kg (based on active ingredient, 4000 mg/kg based on test substance) was found to be a No-Observable-Effect Level (NOEL) for systemic toxicity under the conditions of this study.