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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:
26 May 2015 to 26 October 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Tall Oil Fatty Acids, compounds with 2-(2-aminoethoxy) ethanol
Molecular formula:
Too complex
IUPAC Name:
Tall Oil Fatty Acids, compounds with 2-(2-aminoethoxy) ethanol
Test material form:
liquid
Details on test material:
- Appearance/ Physical State: light brown slightly viscous liquid
- Storage conditions: room temperature, in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
ANIMALS AND ANIMAL HUSBANDRY
- Two New Zealand White rabbits were supplied by Envigo RMS (UK) Limited, Leicestershire, UK.
- At the start of the study the animals weighed 2.3 kg or 3.02 kg and were 12 to 20 weeks old.
- After an acclimatisation period of at least 5 days each animal was given a number unique within the study, which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
- Animals were individually housed in suspended metal cages.
- Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study.
- The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Temperature and relative humidity were set to achieve limits of 17 °C to 23 °C and 30 % to 70 % respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- The rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
- Animals were provided with environmental enrichment items, which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
Four hours
Observation period:
Seven days
Number of animals:
Two
Details on study design:
PREPARATION OF TEST MATERIAL
- The absorption of the test item was not determined.

MEASUREMENT OF pH
- The pH of the test material was determined prior to commencement of the study and found to be 9.31 (as supplied), 8.88 (90 % v/v aqueous preparation) and 8.51 (90 % v/v aqueous preparation after 10 minutes).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 75201 (male)
Remarks:
Slight desquamation at 7 d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 75202 (male)
Remarks:
Slight desquamation at 7 d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 75201 (male)
Remarks:
Slight desquamation at 7 d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 75202 (male)
Remarks:
Slight desquamation at 7 d
Irritant / corrosive response data:
- Individual scores and mean scores for erythema/eschar and edema are given in Table 1 (attached).
- Very slight erythema and very slight or slight edema were noted at both treated skin sites 1 hour after patch removal.
- Well defined erythema and slight edema were noted at both treated skin sites at the 24, 48 and 72-hour observations.
- Light brown discolouration of the epidermis was noted at one treated skin site at the 24 and 48-hour observations and at both treated skin sites at the 72-hour observation.
- Loss of skin flexibility and/or elasticity was noted at one treated skin site at the 24-hour observation and at both treated skin sites at the 48 and 72-hour observations.
- Slight desquamation was noted at both treated skin sites at the 7-day observation.
Other effects:
- Individual body weights and body weight changes are given in Table 2 (attached).
- Both animals showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritancy potential of the test item was assessed in accordance with OECD Guideline 404. The test item produced individual mean scores for both animals of 2.0 for erythema and 2.0 for edema. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted. As such, the test item does not meet the criteria for classification.
Executive summary:

INTRODUCTION

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002) and Commission Directive 92/69/EEC Method B.4 Acute Toxicity (Skin Irritation).

RESULTS

A single 4 -hour, semi-occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and slight edema. Other skin reactions noted were light brown discolouration of the epidermis, loss of skin elasticity and flexibility and slight desquamation.

CONCLUSION

The test item produced individual mean scores for both animals of 2.0 for erythema and 2.0 for edema. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted.