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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The purpose of the study was to evaluate the local irritating/corrosive effects on the rabbit skin following a single application of the test chemical
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material : Tetrylammonium bromide
- IUPAC name: N,N,N-triethylethanaminium bromide
- Molecular formula: C8 H20 N.Br
- Molecular weight: 210.157 g/mol
- Smiles notation: [N+](CC)(CC)(CC)CC.[BrH-]
- InChl : 1S/C8H20N.BrH/c1-5-9(6-2,7-3)8-4;/h5-8H2,1-4H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid crystalline powder (white)
- Purity: 99.23%
Specific details on test material used for the study:
- Name of test material (as cited in study report): Tetrylammonium bromide- Molecular formula: C8H20N.Br- Molecular weight: 210.157 g/mol- Smiles notation: [N+](CC)(CC)(CC)CC.[BrH-]- InChl : 1S/C8H20N.BrH/c1-5-9(6-2,7-3)8-4;/h5-8H2,1-4H3;1H/q+1;/p-1- Substance type: Organic- Physical state: solid- Purity: 100.1 -100.2% based on Br-- Storage: At ambient temperature in the dark- Batch No: HH 85-83A

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Sex: Female - Source: The Broekmen Institute, Someren, The Netherlands - Age at study initiation: 2- 3 months old - Weight at study initiation: 2617- 2751 g - Housing: individually housed in metal cages with perforated floors - Diet (e.g. ad libitum): standard lab diet (100g/ day); obtained from Hope Farms - Water (e.g. ad libitum): tap water, ad libitum - Acclimation period: A quarantine period of 12 days followed by another 3 weeks of acclimation period ENVIRONMENTAL CONDITIONS - Temperature (°C): 20 - 21 degC - Humidity (%): 60 -70% (relative humidity) - Air changes (per hr): no data available - Photoperiod (hrs dark / hrs light): 12 hours ligth, 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes
Amount / concentration applied:
0.5 gm of test substance moistened with 0.5 ml of milli RO water
Duration of treatment / exposure:
4 hours
Observation period:
responses were scored at 60 minutes then 24, 48, 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE - Area of exposure: left flank, central flank - % coverage: 6cm square patch of Metalline, mounted on a permeable tape - Type of wrap if used: flexible bandage (COBAN, 3M, USA) REMOVAL OF TEST SUBSTANCE - Washing (if done): yes - Time after start of exposure: 4 hours after exposure of the test chemicalOBSERVATION TIME POINTS(indicate if minutes, hours or days) : The exposed areas were examined for signs of erythema and edema and the responses were scored at 60 minutes then 24, 48, 72 hours after patch removalSCORING SYSTEM: - Method of calculation:The test reaults were evaluated according to the EEC criteria for classification and labelling of dangerous substances (Annex VI of the EEC Council directive 67/548/EEC as amended by Directive 83/467/EEC)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The skin of all 3 animals did not show any reactions.Signs of systemic intoxication were not observed.

Any other information on results incl. tables

Table 1: Primary Skin Irritation Scores for TEAB in the rabbit

Rabbit No. and Sex

Body Weight (gm)

Observation time after exposure period (hours)

Erythema

Edema

269, Female

2617

1

0

0

24

0

0

48

0

0

72

0

0

Subtotala)/ Mean valuec)

 

 

 

 

0/0

0/0

271, Female

2751

1

0

0

24

0

0

48

0

0

72

0

0

Subtotala)/ Mean valuec)

 

 

 

 

0/0

0/0

276, Female

2646

1

0

0

24

0

0

48

0

0

72

0

0

Subtotala)/ Mean valuec)

 

 

 

 

0/0

0/0

Totalb)/ Mean value

 

 

0/0

0/0

Where,

a)Subtotal = sum of 24,48,72 hours scores for each animals individually

b)Total = sum of 24, 48, 72 hours scores calculated over all animals

c)Mean value = mean score of 24,48 and 72 hours reading time

   

Primary Irritation Index (PII)*= 0

*- Total of 24 and 72 hours scores for erythema and edema, divided by 6

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The skin of all 3 animals did not show any reactions.Signs of systemic intoxication were not observed.The Primary Irritation Index (PII) of the test chemical was 0.0
Based on these results and applying the EEC criteria for classification and labelling of dangerous substances (Annex VI of the EEC Council directive 67/548/EEC as amended by Directive 83/467/EEC), the test chemical need not be labelled as Skin Irritant.
Executive summary:

The test chemical was applied in a single dose to the skin of the experimental animals, each animal serving as its own control.The degree of irritation was evaluated and scored according to OECD 404 Guidelines at specific intervals.

3 young adult female New Zealand White rabbits were used for the study. One day before dose administration, the fur was removed from the central back of the rabbits by clipping, exposing an area of skin of approximately 10*10 cm. 0.5 gm of test substance moistened with 0.5 ml of milli RO water  was applied on  6cm square patch of Metalline, mounted on a permeable tape.this was applied to the left flank of each animal.The right flank being covered with same dressing with the test chemical served as control.Finally the animals were wrapped in a flexible bandage. The exposure duration was 4 hours, after which the remaining test substance was gently removed using a tissue moistened with tap-water. The exposed areas were examined for signs of erythema and edema and the responses were scored at 60 minutes then 24, 48, 72 hours after patch removal. The test results were evaluated according to the EEC criteria for classification and labelling of dangerous substances (Annex VI of the EEC Council directive 67/548/EEC as amended by Directive 83/467/EEC).

The skin of all 3 animals did not show any reactions.Signs of systemic intoxication were not observed.The Primary Irritation Index (PII) of the test chemical was 0.0

Based on these results and applying the EEC criteria for classification and labelling of dangerous substances (Annex VI of the EEC Council directive 67/548/EEC as amended by Directive 83/467/EEC), the test chemical need not be labelled as Skin Irritant.