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Diss Factsheets

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:
1991-07-22 until 1991-08-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to internationally accepted testing guideline, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
para-Dodecylphenol
IUPAC Name:
para-Dodecylphenol
Constituent 2
Chemical structure
Reference substance name:
Phenol, dodecyl-, branched
EC Number:
310-154-3
EC Name:
Phenol, dodecyl-, branched
Cas Number:
121158-58-5
Molecular formula:
C18H30O
IUPAC Name:
4-(3,4,5,6-tetramethyloctan-2-yl)phenol
Details on test material:
- Name of test material (as cited in study report): Dodecylphenol T
- Molecular formula (if other than submission substance):
- Physical state: liquid
- Analytical purity: 98.6%
- Impurities (identity and concentrations): 1.4% ortho-Dodecylphenol
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: 3630/81 325
- Production date of the lot/batch: 1991-04-25
- Stability under test conditions: April 1992
- Storage condition of test material: closed bottle, under nitrogen atmosphere in the darkness

Test animals

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMAL
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: healthy adult
- Weight at study initiation: 2 - 3 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk Haltern, Germany
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
3 minutes
Observation period:
1, 24, 48 and 72 hours and 6, 8, 10, 14, 15 and 17 days after application.
Number of animals:
1 male
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral part of the trunk of the animal.
- % coverage: not mentioned
- Type of wrap if used: the skin was covered with a mull patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance residues are carefully washed off with warm water.
- Time after start of exposure: 3 minutes

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
8
Reversibility:
not fully reversible within: 17 days
Remarks on result:
other: scar formation
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 4.0
- Edema: 4.0
Other effects:
After 24 h the animal showed necrosis, after 48 h dristinctively edema, on days 10-15 eschar and crust.

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

male: 1

male: 1

30-60 min

2

0

24 h

4

4

48 h

4

4

72 h

4

4

Average 24h, 48h, 72h

 4.00

 4.00

Reversibility*)

 n.

n. 

Average time (unit) for reversion

scar formation

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results from the skin irritation studies indicate that TPP is a severe skin irritant. Classification with R38 is proposed on the basis that the mean value of the scores for both erythema and oedema in the most reliable study are 2 and the effects persisted until the end of the observation period in at least 2 animals. There was no clear evidence of full thickness tissue destruction consistent with corrosivity.