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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
Study period:
03 - 24 Feb 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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
dressing was occlusive, 24 h exposure, no experimental 48 h reading performed, no data for the observation period given
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Dimethylamino-2-methyl-1-propanol, 73% DMAMP, Polymeen A (P-2614)
- Substance type: clear, pale yellow liquid
- Analytical purity: 72.03%
- Lot/batch No.: 730H18DF36
- pH: 12.5
Specific details on test material used for the study:
- Lot No, 73 0H18DF3 6
- 2-Dimethylamino-2-methyl-1-propanol 72.03%
- APHA (color) 15
- pH 12.5
- Sp. Gr. 0.947
- Made from DMAMP 80 Lot No. OH18DF36

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.6 ± 0.3 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
21 days
Reading time points: 24 and 72h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: The skin from the back of each rabbit was clipped free of hair. Two intact skin sites and two abraded sites were used for exposure.
- Type of wrap if used: the exposed skin area was covered with gauze and the trunk wrapped in a rubberised impervious cloth and a flexible wire screen held in place with tape, respectively

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin areas were cleaned
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: the animal was sacrificed after Day 1 due to a broken leg
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
out of animal 2, 3, 4, 5 and 6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: the animal was sacrificed on Day 1 due to a broken leg
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritant / corrosive response data:
At the 24-hour time point, severe erythema and moderate to severe edema was noted at the intact skin sites of all rabbits (see Table 1). One rabbit broke its leg on day 1 and was sacrificed. For the remaining 5 animals, the erythema was equally severe at the 72-hour time point, while the edema was completely reversed. The treated intact skin sites were still affected by erythema and edema on day 21, although the effects were less severe with signs of healing. The effects on abraded skin were the same as on the intact skin.
Other effects:
There were no effects on the body weight of the animals.

Any other information on results incl. tables

Table 1: individual erythema and edema scores for intact skin

Observation time

Rabbit No.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

4

2

4

4

4

3

4

2

4

3

4

3

48 h

No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

 

72 h

*

*

4

0

4

0

4

0

4

0

4

0

* rabbit sacrificed on day 1 due to a broken leg

Table 2: calculation of mean scores for intact skin

 

Rabbit No.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value 24+48+72 h

*

*

4

2.67

4

2

4

1.33

4

2

4

2

* rabbit sacrificed on day 1 due to a broken leg

Applicant's summary and conclusion

Interpretation of results:
irritating
Conclusions:
CLP: Cat. 2, H315
DSD: Xi, R38
Executive summary:

The primary skin irritation study was conducted on DMAMP as supplied. The test was conducted on a group of six albino rabbits weighing from 2.650.3 kg. The skin from the back area of each rabbit was clipped free of hair. The skin on the left side of the middorsal line was left intact while the skin on the right side was abraded at two sites by making minor epidermal incisions in a tic-tac-toe pattern with a blunt hypodermic needle. The abrasions were minor incisions through the stratum corneum, but not deep enough to disturb the dema or produce bleeding. A 0.5 ml of P-2614 as supplied was applied to each site , two intact and two abraded, and covered with a gauze pad. The entire trunk was then wrapped with a rubberized impervious cloth and a flexible wire screen held in place by tape. After 24 h exposure, the bindings and patches were removed and the treated sites were gently cleaned. The skin reactions were scored immediately (24 h) and a t the end of 72 h (48 h after first scoring).

At 24 h the test material produced erythema and edema on the intact skin but produced moderate to severe erythema and edema on the abraded skin sites . One of the rabbits broke its leg a fter one day on treatment, so the animal was sacrificed. The average irritation score for the five rabbits was 5.5 + 0.4. Since the material produced severe skin irritation , the animals were held for observation up to 21 days. The treated skin sites were not normal by day 21, but the skin sites showed erythema and slight healing. The average body weight gains of the treated animals were normal.