Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
7-05-1987 until 21-05-1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No batch no. or composition, but test material data sheet included. All other data available. Study is GLP and according to guideline. Results potentially biased by cleaning procedure after exposure, see other available study on irritation.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
see remarks below
Principles of method if other than guideline:
Three test animals were exposed for 3 min, 1 hr and 4 hrs, at the same time and not sequentially.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, N-(3-aminopropyl)-N’-[3-(C16-18 (even numbered) and C18 unsaturated alkyl amino)propyl]trimethylenedi- and amines, N-(3-aminopropyl)-N’-(C16-18 (even numbered) and C18 unsaturated alkyl)trimethylenedi-
Molecular formula:
UVCB - No molecular formula; Avg mw = 390.26 mw C16 Tetramine = 412.751 mw C18 Tetramine = 440.805
IUPAC Name:
Amines, N-(3-aminopropyl)-N’-[3-(C16-18 (even numbered) and C18 unsaturated alkyl amino)propyl]trimethylenedi- and amines, N-(3-aminopropyl)-N’-(C16-18 (even numbered) and C18 unsaturated alkyl)trimethylenedi-
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Tallow tripropylenetetramine
- Substance type: White paste
- Physical state: solid
- Analytical purity: (Certificate of Analysis is included in report)
- Impurities (identity and concentrations): Free Acrylonitrile < 4ppm and water 0,2%
- Composition of test material: see Certificate of Analysis.
- Purity test date: 05 February 2009
- Lot/batch No.: S001255
- Expiration date of the lot/batch: 23 January 2018
- Stability under test conditions: Yes: analytical verification of doses or concentrations performed
- Storage condition of test material: At room temperature in the dark under nitrogen.
- Other:
Density: 850 kg/m3 at 60°C
pH (1% in water, indicative range): 11.0
Stability at higher temperatures: Yes, maximum temperature: 80°C
Maximum duration: several hours
Solubility in Propylene glycol: Unknown

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival, Moston, Sandbach, Chesire, United Kingdom
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.51 - 2.95 kg
- Housing: individually in suspended metal cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 60-68
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
3 minutes, 1 hr and 4 hrs
Observation period:
1 hr after removal of patches and 24, 48 and 72 hours later. Additional observations were made after 7 and 14 days.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: elasticated corset (tubigrip)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in acetone
- Time after start of exposure: 3 min, 1 hr and 4 hrs

SCORING SYSTEM:
- According to Draize (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", see table below.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals 4 hrs exposure
Time point:
other: 24, 48 and 72 hrs
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals 4 hrs exposure
Time point:
other: 24, 48 and 72 hrs
Score:
3.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Four-hour Exposure
Well-defined erythema and moderate oedema , with slight haemorrhage of the dermal capillaries was noted at all test sites one hour after removal of the patches. Light-brown coloured slight eschar surrounded by moderate erythema, with slight to severe oedema were noted at subsequent 24, 48 and 72-hour observations. The eschar persisted at two test sites on day seven with or without desquamation. The skin at the remaining test site was shiny and pink-coloured with continued desquamation, The shiny, pink-coloured skin was noted at all test sites on day fourteen. Desquamation and abnormal fur growth persisted at two test sites on day fourteen.

Any other information on results incl. tables

Summary of dermal lesions (following 4-h application)

no.

Effect

Hour

Days after application

Mean score erythema

24/48/72 h

Mean score oedema

24/48/72 h

1

1

2

3

7

14

60

Erythema/ eschar

Oedema

2H

3

4E

4R

4E

2R

4E

2R

4ED

0

0DP

0

4

2.7

77

Erythema/ eschar

Oedema

2H

3

4E

4R

4E

4R

4E

3R

0DP

0

0DP

0

4

3.7

81

Erythema/ eschar

Oedema

2H

3

4E

4R

4E

4R

4E

4R

4ED

0

0P

0

4

4

Mean

4

3.4

Fa = abnormal fur growth; Fr = reduced fur growth; D = desquamation; T = thickening of skin; R= reactions extending beyond treatment site; Hy = hyperkeratinisation; Br = brown discolourisation of skin; L = loss of skin suppleness; H = haemorrhage of dermal capillaries; Gr = green discoulorisation of skin; Tf = transverse folding of skin; Fi = fissuring of skin; Sc = small scattered scabs; Gs = glossy skin, E = eschar, P = pink coloured and shiny skin

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Maximum irritation with eschar and desquamation were observed which was not reversible within the 14 days observation period, but with signs of skin repair. Although there was no actual necrosis reported, classification as corrosive is prudent.
Executive summary:

A study was performed to assess the effects of Amine 760 on the irritancy potential to the skin of the New Zealand White rabbit. The method used was based on that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion".

A three minute, 1 hour and 4 hours, semi-occluded dermal application of the test material to the intact skin of three rabbits followed by a decontamination procedure with acetone produced irritation scores directly after patch removal and 1,2 and 3 days afterwards.

Results: Maximum scores for erythema were observed in all animals during first 3 days and in two animals accompanied by eschar formation even until day 7, with desquamation in all three animals. At end of observation period on day 14, all animals show pink and shiny skin and in two animals desquamation is still visible. Although the report indicate no visible necrosis, the seriousness of the effects, only partial recovery, and pink shiny colouration indicative of skin recovery after damage, it is probably prudent to classify as corrosive.

Categories Display