2-acrylamido-2-methylpropanesulphonic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14/09/1984-19/10/1984

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:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

2-acrylamido-2-methylpropanesulphonic acid

EC Number:

239-268-0

EC Name:

2-acrylamido-2-methylpropanesulphonic acid

Cas Number:

15214-89-8

Molecular formula:

C7H13NO4S

IUPAC Name:

(1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidic acid

Details on test material:

- Name of test material: OS#63466G
- Substance type: organic
- Physical state: solid
- Analytical purity: not specified
- 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: stable
- Storage condition of test material: not specified

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc, Boyertown (PA), USA
- Age at study initiation: not specified
- Weight at study initiation: 300-500 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes (duration not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-23-9°C (65-75°F)
- Humidity (%): 45-55
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14/09/1984 To: 19/10/1984

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

0.5 g

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

0.5 g

No. of animals per dose:

12

Details on study design:

RANGE FINDING TESTS: No
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: back
- Frequency of applications: 3 times weekly
- Duration: 3 weeks
- Concentrations: 0.5 g

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: all
- Control group:
- Site: back (different area to induction)
- Concentrations: 0.5 g
- Evaluation (hr after challenge): 6, 24 and 48 hours

Positive control substance(s):

yes

Remarks:

l-chloro-2,4-dinitrobenzene

Results and discussion

Positive control results:

The positive control material when tested as a 0.1% w/v suspension in 50% alcohol saline solutionwas considered to be a skin sensitizer in the albino guinea pig.

In vivo (non-LLNA)

Results

Reading:

other: all readings

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 g

No. with + reactions:

0

Total no. in group:

12

Clinical observations:

none

Remarks on result:

other: Reading: other: all readings. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the test conditions, the test substance when dosed as supplied was not considered to be a primary skin irritant, in the albino guinea pig.