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:
key study
Study period:
03 April - 25 May 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
not stated
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts
EC Number:
292-222-1
EC Name:
Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts
Cas Number:
90583-23-6
Molecular formula:
Not applicable, UVCB substance
IUPAC Name:
Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts

Test animals

Species:
rabbit
Strain:
other: Kleinrusse Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: young adult
- Weight at study initiation: 2460 g (mean of all 5 animals)
- Housing: individual cages, Fa. Heinkel, Kuchen, Germany
- Diet: ad libitum (Zucht-/Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen, Germany)
- Water: tap water, ad libitum
- Acclimation period: min. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 50
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted
Duration of treatment / exposure:
4 h
Observation period:
21 days
Reading time points: 1, 24, 48 and 72 h and 7, 10, 14, 17, and 21 days
Number of animals:
5 males
Details on study design:
TEST SITE
- Area of exposure: undiluted test substance was applied to a 2.5 cm x 2.5 cm linen patch
- Type of wrap if used: the patch was fixed to the clipped skin by means of a plastics foil (not further specified) and secured occlusively with adhesive Acrylastics tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed/rinsed off
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 5 animals
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
other: mean of 4 animals (except animal #3)
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Individual erythema and edema scores are summarised in the table in section “Any other information on results incl. tables”. 1 h after removal of the patch moderate to severe erythema (scores 3 and 4) and edema (scores of 2 and 3) were observed in all animals. Erythema (score 2 in 1/5 animals, score 3 in 2/5 animals and score 4 in 2/5 animals) and edema (score 2 in 3/5 animals, score 3 in 1/5 animals and score 4 in 1/5 animals) were still visible at the reading 10 days after exposure to the test substance. At day 14 of the observation period, erythema and edema started to reverse: erythema score 1 in 3/5 and score 2 in the other 2 animals at day 14 and score 0 in 3/5 animals and score 2 in 2/3 animals on day 17; edema score 1 in 4/5 animals and score 0 in the remaining animals on day 14. At the last observation on day 21, all erythema and edema were fully reversed in all animals.

In addition to erythema and edema formation, a brownish discoloration developed in 5/5 animals 24 h after exposure. The discoloration was still detectable in 2/5 animals after 10 days, whereas after 14 days it was also completely reversed in the remaining 2 animals. 7 days after exposure to the test substance eschar formation was observed in all 5 animals. Eschars remained visible in 4/5 animals until day 17 of the obseration period. 1/5 animals exhibited eschars until the end of the test on day 21 while the other 4 animals were free of eschars at that observation point.
Other effects:
No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1: Individual skin examination scores after 4h-exposure to Texapon MGS (Scoring according to Draize scheme)

 

Skin effect

Erythema

Edema

Scoringa

1

h

24h

48h

72h

7

d

14d

21 d

Meanb

1

h

24h

48h

72h

7

d

14d

21 d

Meanb

Animal No. /sex

#1

4

4

4

4

4

1

0

4.0

2

4

4

4

4

1

0

4.0

#2

3

4

4

4

4

1

0

4.0

2

4

4

4

3

0

0

4.0

#3

3

4

4

4

4

1

0

4.0

1

3

3

4

4

1

0

3.3

#4

3

4

4

4

4

2

0

4.0

2

4

4

4

3

1

0

4.0

#5

2

4

4

4

4

2

0

4.0

2

4

4

4

4

1

0

4.0

aTimepoint of reading after substance removal subsequent to 4h-dermal exposure

bMean of 24, 48 and 72 h scores

Applicant's summary and conclusion

Interpretation of results:
other: Skin irrit. 2, H315. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)