Formaldehyde, reaction products with diethanolamine and 6(or 7)-methyl-1H-benzotriazole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 8, 1982 - February 15, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(24 h exposure, occlusive treatment, observation period)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine

EC Number:

939-703-0

Cas Number:

1474044-75-1

Molecular formula:

C16H19N - C28H43N (main constituents)

IUPAC Name:

Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine

Details on test material:

- Analytical purity: no data
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: UFA Versuchsbetrieb Buehl, CH-5604 Hendschiken
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: standard rabbit foot, NAFAG, No. 814, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated site of the same animal served as control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

7 days (scoring 24, 48 and 72 h and 4 and 7 days after application)

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch covered with an impermeable material, fastened with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM:
- Evaluation according to the Draize Scoring System for abraded and intact skin

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Any other information on results incl. tables

Table 1: results for skin irritation (intact skin):

Observation time	Rabbit no.
	1		2		3		4		5		6
	Ery.	Edema	Ery.	Edema	Ery.	Edema	Ery.	Edema	Ery.	Edema	Ery.	Edema
24 h	2	2	2	1	0	0	2	3	1	0	2	1
48 h	2	2	1	2	0	2	2	2	1	2	1	2
72 h	1	2	0	1	0	2	0	0	0	3	0	3
4 d	2	2	0	1	0	2	0	0	0	3	0	3
7 d	2	2	0	1	0	2	0	0	0	2	0	2
Mean value 24 + 48 + 72 h	1.67	2.00	1.00	1.33	0.00	1.33	1.33	1.67	0.67	1.67	1.00	2.00
Mean value 24 + 48 + 72 h all animals	0.95	1.67	-	-	-	-	-	-	-	-	-	-

Only the values for intact skin were taken in account for classification.

4/6 animals had an average edema score (24 - 72 h) > 1.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the EU CLP regulation the dermal reactions resulting from exposure to the test article are below the level of significance and therefore the substance does not need to be classified.