1,1',1''-nitrilotripropan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Study performed according to internationally accepted testing guideline, well documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1',1''-nitrilotripropan-2-ol

EC Number:

204-528-4

EC Name:

1,1',1''-nitrilotripropan-2-ol

Cas Number:

122-20-3

Molecular formula:

C9H21NO3

IUPAC Name:

1-[bis(2-hydroxypropyl)amino]propan-2-ol

Test material form:

solid

Specific details on test material used for the study:

- Substance type: pure active substance
- Physical state: white crystals
- Analytical purity: approx. 99 %
- Impurities (identity and concentrations): < 1 % Diisopropanolamine

Test animals

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.6 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk Haltern, Germany
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after patch removal

Number of animals:

6 (3 male, 3 female)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, which was covered with a polyethylen film (6 x 6 cm). The application area was then immobilised with an elastic dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

see table 1

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	0/1/0/0/1/0	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0.0	0.0
Reversibility*)	c.	n. a.
Average time (unit) for reversion	60 min.	n. a.

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met