Trometamol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

In vivo study with the rabbit

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 May - 21 May 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

National GLP Compliance Monitoring Authority, Department of Science & Technology, New Delhi, India

Test material

Test material information

Constituent 1

Reference substance name:

Trometamol

EC Number:

201-064-4

EC Name:

Trometamol

Cas Number:

77-86-1

Molecular formula:

C4H11NO3

IUPAC Name:

2-amino-2-(hydroxymethyl)propane-1,3-diol

Details on test material:

- Name of test material (as cited in study report): Tris Amino Ultra Pure
- Physical state: white crystals
- Analytical purity: 99.9%
- Impurities (identity and concentrations): 0.018% (w/w) water
- Lot/batch No.: XK0731LA1C
- Storage condition of test material: at ambient temperature, 18-36 °C
- Recertification date: 22 Feb 2013
- pH: 10.4 (1% aqueous solution)
- Other: soluble in water

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: in-house bred (Outbred); Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore, India- Age at study initiation: 7-8 months- Weight at study initiation: 2.84-3.06 kg- Housing: the rabbits were housed individually in rabbit cages (approximately L 65 cm x B 65 cm x H 45 cm) with a Noryl shallow cage body and Noryl waste trays. The litter collection trays were changed daily, except on Sundays.The feed hoppers and water bottles were changed weekly. - Diet: rabbit feed (Pranav agro Industries Ltd., Maharashtra, India), ad libitum - Water: deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier (manufactured by Eureka Forbes Ltd., Mumbai, India), ad libitum- Acclimation period: 5 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 21-23- Humidity (%): 59-67- Air changes (per hr): 12-15- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: 13 May 2011 To: 21 May 2011

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: water was added to the test substance to make a paste

Controls:

other: not required, untreated sites of the same animal served as the control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

72 hReading time points: 1, 24, 48 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE- Area of exposure: approximately 6 cm²- Type of wrap if used: the test substance was applied to the skin and the area was covered with a semi-occlusive patch. The patch was held in place with non-irritating semi-occlusive adhesive tape that was wrapped around the trunk of the animals. The rabbits were also fitted with an Elizabethan collar for 24 hours after application.REMOVAL OF TEST SUBSTANCE- Washing (if done): the application sites were washed with water and wiped clean with a towel to remove any residual test substance- Time after start of exposure: 4 hTEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g- For solids, paste formed: yesSCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: reversibility not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: reversibility not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin irritation effects were observed; all scores were 0 at all reading time points for 3/3 animals.

Other effects:

There was no mortality and no clinical signs of toxicity were observed during the study period. The body weight gains were within the normal ranges during the study period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

There were no skin reactions observed at any time point during the study.
CLP: not classified
DSD: not classified

Executive summary:

The acute dermal irritation study in rabbits was conducted to evaluate the skin irritation potential of Tris Amino Ultra Pure. Under the testing conditions of this study, the test substance Tris Amino Ultra Pure showed no evidence of dermal irritation. Five hundred mg (0.5g) of the test substance was made into a paste with a sufficient volume of water and mixed with a glass rod. The resulting paste was applied to the dose site and covered with a gauze pad of approximately 6 cm2 (2 x 3 cm - 6ply). The patch was secured to the body of the animal by a non-irritating semi-occlusive adhesive tape. After a 4-hour contact period, the bandage was removed and the dose site was wiped with water using clean towels. Three rabbits were treated at once. The degree of irritation was evaluated and scored by Draize’s evaluation method at 1, 24, 48 and 72 hours post removal of the test patch. There were no clinical signs of toxicity or pre-terminal deaths. There were no skin reactions observed at any time point during the study.