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Administrative data

Description of key information

- corrosive to the skin

- classification for skin corrosion leads to classification for serious eye damage (cat. 1)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 May 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive dressing; no information on skin reactions after 3 min of exposure)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, UK
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 3.46 kg
- Housing: single in a grid floor cage
- Diet: Standard Rabbit Diet (Special Diets Services Ltd., Stepfield, Witham, Essex, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13 - 20
- Humidity (%): 40 - 47
- Photoperiod (hrs dark / hrs light): 10 / 14
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

Duration of treatment / exposure:
1 h (the study was terminated after 1 h for humane reasons)
Observation period:
The study was terminated after 1 h of treatment for humane reasons.
Number of animals:
1 female animal (owing to the very high pH of the diluted test article)
Details on study design:
TEST SITE
- Area of exposure: back (6 cm2)
- Type of wrap if used: gauze patch; the patch was occluded and secured using a strip of impermeable adhesive tape (Sleek, Smith & Nephew, Welwyn Garden City, Herts, UK)

REMOVAL OF TEST SUBSTANCE
- Washing: The skin wiped gently with a disposable paper towel moistened with water.
- Time after start of exposure: 1 h

SCORING SYSTEM: Immediately on removal of the patches severe tissue damage was observed. No scoring of the skin irritation could be made. The animal was killed and the study terminated for humane reasons.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: corrosive
Remarks:
The study was terminated after 1 h and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated. Hence, reversibility of the local effects could not be determined.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: corrosive
Remarks:
The study was terminated after 1 h and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated. Hence, reversibility of the local effects could not be determined.
Irritant / corrosive response data:
Vocalisation was noted 2 minutes after application of the test article. The patch was removed after one hour and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Skin corr. 1B, H314
Executive summary:

The study was performed 1982, following the DOT (Transport Classification) Guidelines. The study was terminated after 1 h and the animal was killed for humane reasons. Therefore, the substance is classified as skin corrosive 1B, H314 according to Regulation (EC) 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The skin irritation study was performed 1982, following the DOT (Transport Classification) Guidelines.The study was terminated after 1 h and the animal was killed for humane reasons. Therefore, the substance is classified as skin corrosive 1B, H314 according to Regulation (EC) 1272/2008.

Eye irritation:

According to Column 2 of REACH Annex VII an in vivo eye irritation study (required in Section 8.2 of REACH Annex VII) does not need to be conducted if 1) the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes, or 2) the substance is flammable in air at room temperature. As the test substance is a strong base (pH > 11.5) and meets the classification criteria both for Skin corr. 1B, H314 and Flam. Liquid 3 according to Regulation EC 1272/2008, no eye irritation study is needed to fulfill the data requirements defined in REACH Annex VII.



Justification for classification or non-classification

Due to the reuslts of an in vivo skin irritation study, tetramethylguanidine is classified as skin corrosive 1B, H314 according to the regulation (EC) 1272/2008 (CLP).

According to the REACH regulation (EC) 1907/2006, annex VII, 8.2. column 2, no eye irritation study is needed because the test substance is a strong base (pH > 11.5) and meets the classification criteria both for Skin corr. 1B, H314 and Flam. Liquid 3 according to Regulation EC 1272/2008.